Cetuximab and/or Bevacizumab Combined With Combination Chemotherapy in Treating Patients With Metastatic Colorectal Cancer

April 28, 2020 updated by: Alliance for Clinical Trials in Oncology

A Phase III Trial of Irinotecan / 5-FU / Leucovorin or Oxaliplatin / 5-FU/ Leucovorin With Bevacizumab, or Cetuximab (C225), or With the Combination of Bevacizumab and Cetuximab for Patients With Untreated Metastatic Adenocarcinoma of the Colon or Rectum

PURPOSE: This randomized phase III trial is studying cetuximab and/or bevacizumab when given together with combination chemotherapy to compare how well they work in treating patients with metastatic colorectal cancer.

RATIONALE: Monoclonal antibodies, such as cetuximab and bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Cetuximab may also stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Drugs used in chemotherapy, such as fluorouracil, leucovorin, oxaliplatin, and irinotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving monoclonal antibodies together with combination chemotherapy may kill more tumor cells. It is not yet known whether combination chemotherapy is more effective with cetuximab and/or bevacizumab in treating patients with colorectal cancer.

Study Overview

Status

Completed

Conditions

Colorectal Cancer

Intervention / Treatment

Detailed Description

OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to physician-selected chemotherapy (FOLFOX or FOLFIRI), prior adjuvant chemotherapy (yes vs no), and prior pelvic radiotherapy (yes vs no). Patients were randomized to 1 of 3 treatment arms.

Primary Objective:

To determine if the addition of cetuximab to FOLFIRI or FOLFOX chemotherapy prolongs survival compared to FOLFIRI or FOLFOX with bevacizumab in patients with untreated, advanced or metastatic colorectal cancer who have K-ras wild type tumors.

Secondary Objectives:

To evaluate response, progression-free survival (PFS), time to treatment failure (TTF), and duration of response (DR) among patients with unresectable advanced metastatic colon cancer treated with bevacizumab or cetuximab in addition to chemotherapy with FOLFIRI or FOLFOX
To evaluate toxicity and, in particular, 60-day mortality among patients with unresectable advanced metastatic colon cancer treated with bevacizumab or cetuximab in addition to chemotherapy with FOLFIRI or FOLFOX
To describe patients with unresectable locally advanced or metastatic colorectal cancer rendered "resectable" with chemotherapy

There are premedication guidelines that were established for patients assigned to receive cetuximab. All patients must be premedicated with diphenhydramine hydrochloride 50 mg (or a similar agent) IV prior to the first dose of cetuximab in an effort to prevent an infusion or hypersensitivity reaction. Premedication is also recommended prior to subsequent doses, but at the investigator's discretion the dose of diphenhydramine (or a similar agent) may be reduced. Pretreatment with acetaminophen may also be used.

There are bevacizumab administration instructions for patients for whom surgery is being contemplated or required. For patients for whom elective surgery is contemplated, bevacizumab is to be discontinued for at least 8 weeks prior to surgery. Bevacizumab may be resumed after at least 4 weeks following surgery. Patients who undergo complete resection of metastatic disease will discontinue protocol therapy and may receive further treatment at the treating physician's discretion. For patients for whom non-elective surgery is required, hold bevacizumab as long as possible prior to surgery and for at least 6 weeks following surgery.

Patients received a minimum of two cycles of therapy. Patients were allowed to receive ancillary therapy per protocol. Treatment continued until disease progression, unacceptable toxicity, or surgery with curative intent as planned. After completion of study treatment, patients are followed up to 5 years.

Study Type

Interventional

Enrollment (Actual)

2334

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Canada
- British Columbia
  - Kelowna, British Columbia, Canada, V1Y 5L3
    - British Columbia Cancer Agency - Centre for the Southern Interior
  - Vancouver, British Columbia, Canada, V5Z 4E6
    - British Columbia Cancer Agency - Vancouver Cancer Centre
- Manitoba
  - Winnipeg, Manitoba, Canada, R3E 0V9
    - CancerCare Manitoba
- New Brunswick
  - Saint John, New Brunswick, Canada, E2L 4L2
    - Saint John Regional Hospital
- Ontario
  - Hamilton, Ontario, Canada, L8V 5C2
    - Margaret and Charles Juravinski Cancer Centre
  - Kingston, Ontario, Canada, K7L 5P9
    - Cancer Centre of Southeastern Ontario At Kingston General Hospital
  - Kitchener, Ontario, Canada, N2G 1G3
    - Grand River Regional Cancer Centre at Grand River Hospital
  - London, Ontario, Canada, N6A 4L6
    - London Regional Cancer Program at London Health Sciences Centre
  - Newmarket, Ontario, Canada, L3Y 2P9
    - Southlake Regional Health Centre
  - Oshawa, Ontario, Canada, L1G 2B9
    - R. S. McLaughlin Durham Regional Cancer Centre at Lakeridge Health Oshawa
  - Ottawa, Ontario, Canada, K1H 1C4
    - Ottawa Hospital Regional Cancer Centre - General Campus
  - Saint Catharines, Ontario, Canada, L2R 2Z7
    - St. Catharines General Hospital at Niagara Health System
  - Thunder Bay, Ontario, Canada, P7B 6V4
    - Cancer Care Program at Thunder Bay Regional Health Sciences
  - Toronto, Ontario, Canada, M4C 3E7
    - Toronto East General Hospital
  - Toronto, Ontario, Canada, M5B 1W8
    - St. Michael's Hospital - Toronto
  - Toronto, Ontario, Canada, M5G 2M9
    - Princess Margaret Hospital
  - Toronto, Ontario, Canada, M9C 1A5
    - Trillium Health Centre - Mississauga Site
  - Toronto, Ontario, Canada, M4N 3M5
    - Odette Cancer Centre at Sunnybrook
  - Windsor, Ontario, Canada, N8W 2X3
    - Windsor Regional Cancer Centre at Windsor Regional Hospital
- Saskatchewan
  - Regina, Saskatchewan, Canada, S4T 7T1
    - Allan Blair Cancer Centre at Pasqua Hospital
  - Saskatoon, Saskatchewan, Canada, S7N 4H4
    - Saskatoon Cancer Centre at the University of Saskatchewan
United States
- Alabama
  - Mobile, Alabama, United States, 36608
    - Providence Cancer Center at Providence Hospital
- Alaska
  - Anchorage, Alaska, United States, 99508
    - Providence Cancer Center
  - Anchorage, Alaska, United States, 99508
    - Alaska Regional Hospital Cancer Center
- Arkansas
  - Fort Smith, Arkansas, United States, 72903
    - Hembree Mercy Cancer Center at St. Edward Mercy Medical Center
  - Jonesboro, Arkansas, United States, 72401
    - NEA Medical Center - Stadium Boulevard
- California
  - Burbank, California, United States, 91505
    - Roy and Patricia Disney Family Cancer Center at Providence Saint Joseph Medical Center
  - Castro Valley, California, United States, 94546
    - East Bay Radiation Oncology Center
  - Castro Valley, California, United States, 94546
    - Valley Medical Oncology Consultants - Castro Valley
  - Fairfield, California, United States, 94533
    - North Bay Cancer Center
  - Fremont, California, United States, 94538
    - Kaiser Permanente - Fremont
  - Fremont, California, United States, 94538
    - Valley Medical Oncology
  - Glendale, California, United States, 91204
    - Glendale Memorial Hospital Comprehensive Cancer Center
  - Greenbrae, California, United States, 94904
    - California Cancer Care, Incorporated - Greenbrae
  - Hayward, California, United States, 94545
    - Kaiser Permanente Medical Center - Hayward
  - Loma Linda, California, United States, 92357
    - Veterans Affairs Medical Center - Loma Linda (Pettis)
  - Los Angeles, California, United States, 90089-9181
    - USC/Norris Comprehensive Cancer Center and Hospital
  - Martinez, California, United States, 94553-3156
    - Contra Costa Regional Medical Center
  - Marysville, California, United States, 95901
    - Tibotec Therapeutics - Division of Ortho Biotech Products, LP
  - Mountain View, California, United States, 94040
    - El Camino Hospital Cancer Center
  - Mountain View, California, United States, 94040
    - Camino Medical Group - Treatment Center
  - Oakland, California, United States, 94609
    - Alta Bates Summit Medical Center - Summit Campus
  - Oakland, California, United States, 94609
    - Larry G Strieff MD Medical Corporation
  - Oakland, California, United States, 94609
    - CCOP - Bay Area Tumor Institute
  - Oakland, California, United States, 94609
    - Bay Area Breast Surgeons, Incorporated
  - Oakland, California, United States, 94609
    - Tom K Lee, Incorporated
  - Oakland, California, United States, 94611
    - Kaiser Permanente Medical Center - Oakland
  - Orange, California, United States, 92868
    - St. Joseph Hospital Regional Cancer Center - Orange
  - Palm Springs, California, United States, 92262
    - Desert Regional Medical Center Comprehensive Cancer Center
  - Palo Alto, California, United States, 94301
    - Palo Alto Medical Foundation
  - Pleasanton, California, United States, 94588
    - Valley Medical Oncology Consultants - Pleasanton
  - Redwood City, California, United States, 94063
    - Kaiser Permanente Medical Center - Redwood City
  - Richmond, California, United States, 94801
    - Kaiser Permanente Medical Center - Richmond
  - Roseville, California, United States, 95661
    - Kaiser Permanente Medical Center - Roseville
  - Sacramento, California, United States, 95817
    - University of California Davis Cancer Center
  - Sacramento, California, United States, 95823
    - South Sacramento Kaiser-Permanente Medical Center
  - Sacramento, California, United States, 95825
    - Kaiser Permanente Medical Center - Sacramento
  - Saint Helena, California, United States, 94574
    - Saint Helena Hospital
  - San Diego, California, United States, 92134
    - Naval Medical Center - San Diego
  - San Diego, California, United States, 92108
    - Kaiser Permanente Medical Office -Vandever Medical Office
  - San Francisco, California, United States, 94115
    - UCSF Helen Diller Family Comprehensive Cancer Center
  - San Francisco, California, United States, 94115
    - Kaiser Permanente Medical Center - San Francisco Geary Campus
  - San Francisco, California, United States, 94110
    - San Francisco General Hospital Medical Center
  - San Jose, California, United States, 95119
    - Kaiser Permanente Medical Center - Santa Teresa
  - San Rafael, California, United States, 94903
    - Kaiser Foundation Hospital - San Rafael
  - Santa Clara, California, United States, 95051
    - Kaiser Permanente Medical Center - Santa Clara Kiely Campus
  - Santa Rosa, California, United States, 95403
    - Kaiser Permanente Medical Center - Santa Rosa
  - South San Francisco, California, United States, 94080
    - Kaiser Permanente Medical Center - South San Francisco
  - Stockton, California, United States, 95210
    - Kaiser Permanente Medical Facility - Stockton
  - Truckee, California, United States, 96161
    - Tahoe Forest Cancer Center
  - Vallejo, California, United States, 94589
    - Kaiser Permanente Medical Center - Vallejo
  - Walnut Creek, California, United States, 94596
    - Kaiser Permanente Medical Center - Walnut Creek
- Colorado
  - Alamosa, Colorado, United States, 81101
    - San Luis Valley Regional Medical Center
  - Aurora, Colorado, United States, 80045
    - University of Colorado Cancer Center at UC Health Sciences Center
  - Aurora, Colorado, United States, 80012
    - Aurora Presbyterian Hospital
  - Boulder, Colorado, United States, 80301-9019
    - Boulder Community Hospital
  - Colorado Springs, Colorado, United States, 80933
    - Penrose Cancer Center at Penrose Hospital
  - Colorado Springs, Colorado, United States, 80909
    - Memorial Hospital Cancer Center - Colorado Springs
  - Denver, Colorado, United States, 80210
    - Porter Adventist Hospital
  - Denver, Colorado, United States, 80220
    - Veterans Affairs Medical Center - Denver
  - Denver, Colorado, United States, 80220
    - Rose Medical Center
  - Denver, Colorado, United States, 80204
    - Denver Health Medical Center
  - Denver, Colorado, United States, 80218
    - Presbyterian - St. Luke's Medical Center
  - Denver, Colorado, United States, 80204
    - St. Anthony Central Hospital
  - Denver, Colorado, United States, 80218
    - St. Joseph Hospital
  - Denver, Colorado, United States, 80224-2522
    - CCOP - Colorado Cancer Research Program
  - Denver, Colorado, United States, 80205
    - Kaiser Permanente - Denver
  - Edwards, Colorado, United States, 81632
    - Shaw Regional Cancer Center
  - Englewood, Colorado, United States, 80110
    - Swedish Medical Center
  - Fort Collins, Colorado, United States, 80524
    - Poudre Valley Hospital
  - Fort Collins, Colorado, United States, 80528
    - Front Range Cancer Specialists
  - Glenwood Springs, Colorado, United States, 81601
    - Valley View Hospital Cancer Center
  - Grand Junction, Colorado, United States, 81502
    - St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center
  - Greeley, Colorado, United States, 80631
    - North Colorado Medical Center
  - Lafayette, Colorado, United States, 80026
    - Kaiser Permanente - Lafayette
  - Littleton, Colorado, United States, 80122
    - Littleton Adventist Hospital
  - Lone Tree, Colorado, United States, 80124
    - Sky Ridge Medical Center
  - Longmont, Colorado, United States, 80501
    - Hope Cancer Care Center at Longmont United Hospital
  - Loveland, Colorado, United States, 80539
    - McKee Medical Center
  - Montrose, Colorado, United States, 81401
    - Montrose Memorial Hospital Cancer Center
  - Parker, Colorado, United States, 80138
    - Parker Adventist Hospital
  - Pueblo, Colorado, United States, 81004
    - St. Mary - Corwin Regional Medical Center
  - Thornton, Colorado, United States, 80229
    - North Suburban Medical Center
  - Wheat Ridge, Colorado, United States, 80033
    - Exempla Lutheran Medical Center
- Connecticut
  - Greenwich, Connecticut, United States, 06830
    - Bendheim Cancer Center at Greenwich Hospital
  - Hartford, Connecticut, United States, 06105
    - Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center
  - Hartford, Connecticut, United States, 06102-5037
    - Helen and Harry Gray Cancer Center at Hartford Hospital
  - Middletown, Connecticut, United States, 06457
    - Middlesex Hospital Cancer Center
  - New Britain, Connecticut, United States, 06050
    - George Bray Cancer Center at the Hospital of Central Connecticut - New Britain Campus
  - Norwich, Connecticut, United States, 06360
    - Eastern Connecticut Hematology and Oncology Associates
- Delaware
  - Dover, Delaware, United States, 19901
    - Kent General Hospital
  - Lewes, Delaware, United States, 19958
    - Tunnell Cancer Center at Beebe Medical Center
  - Newark, Delaware, United States, 19713
    - CCOP - Christiana Care Health Services
- District of Columbia
  - Washington, District of Columbia, United States, 20016
    - Sibley Memorial Hospital
  - Washington, District of Columbia, United States, 20010
    - Washington Cancer Institute at Washington Hospital Center
- Florida
  - Boca Raton, Florida, United States, 33486
    - Eugene M. and Christine E. Lynn Cancer Institute at Boca Raton Community Hospital - Main Campus
  - Hollywood, Florida, United States, 33021
    - Memorial Cancer Institute at Memorial Regional Hospital
  - Lakeland, Florida, United States, 33805
    - Lakeland Regional Cancer Center at Lakeland Regional Medical Center
  - Orlando, Florida, United States, 32803-1273
    - Florida Hospital Cancer Institute at Florida Hospital Orlando
  - Pensacola, Florida, United States, 32504
    - Sacred Heart Cancer Center at Sacred Heart Hospital
  - Pensacola, Florida, United States, 32514
    - Sacred Heart Medical Oncology
- Georgia
  - Albany, Georgia, United States, 31701
    - Phoebe Cancer Center at Phoebe Putney Memorial Hospital
  - Athens, Georgia, United States, 30607
    - Northeast Georgia Cancer Care, LLC - Medical Oncology
  - Atlanta, Georgia, United States, 30309
    - Piedmont Hospital
  - Atlanta, Georgia, United States, 30342-1611
    - Northside Hospital Cancer Center
  - Atlanta, Georgia, United States, 30342-1701
    - Saint Joseph's Hospital of Atlanta
  - Atlanta, Georgia, United States, 30342
    - CCOP - Atlanta Regional
  - Augusta, Georgia, United States, 30912
    - MBCCOP - Medical College of Georgia Cancer Center
  - Austell, Georgia, United States, 30106
    - WellStar Cobb Hospital
  - Columbus, Georgia, United States, 31904
    - John B. Amos Cancer Center
  - Decatur, Georgia, United States, 30033
    - Charles B. Eberhart Cancer Center at DeKalb Medical Center
  - Decatur, Georgia, United States, 30033
    - Veterans Affairs Medical Center - Atlanta (Decatur)
  - Dublin, Georgia, United States, 31021
    - Dublin Hematology and Oncology Care
  - Fayetteville, Georgia, United States, 30214
    - Piedmont Fayette Hospital
  - Gainesville, Georgia, United States, 30501
    - Northeast Georgia Medical Center
  - Lawrenceville, Georgia, United States, 30045
    - Gwinnett Medical Center
  - Macon, Georgia, United States, 31208
    - Medical Center of Central Georgia
  - Marietta, Georgia, United States, 30060
    - Kennestone Cancer Center at Wellstar Kennestone Hospital
  - Riverdale, Georgia, United States, 30274-2600
    - Southern Regional Medical Center
  - Rome, Georgia, United States, 30165
    - Harbin Clinic Cancer Center - Medical Oncology
  - Savannah, Georgia, United States, 31403-3089
    - Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
  - Savannah, Georgia, United States, 31405
    - Nancy N. and J. C. Lewis Cancer and Research Pavilion at St. Joseph's/Candler
  - Valdosta, Georgia, United States, 31602
    - Pearlman Comprehensive Cancer Center at South Georgia Medical Center
- Hawaii
  - 'Aiea, Hawaii, United States, 96701
    - Kapiolani Medical Center at Pali Momi
  - Honolulu, Hawaii, United States, 96813
    - Cancer Research Center of Hawaii
  - Honolulu, Hawaii, United States, 96826
    - Kapiolani Medical Center for Women and Children
  - Honolulu, Hawaii, United States, 96813
    - OnCare Hawaii, Incorporated - Lusitana
  - Honolulu, Hawaii, United States, 96813
    - Queen's Cancer Institute at Queen's Medical Center
  - Honolulu, Hawaii, United States, 96813
    - Straub Clinic and Hospital, Incorporated
  - Honolulu, Hawaii, United States, 96817
    - Hawaii Medical Center - East
  - Honolulu, Hawaii, United States, 96817
    - OnCare Hawaii, Incorporated - Kuakini
  - Honolulu, Hawaii, United States, 96859
    - Tripler Army Medical Center
  - Honolulu, Hawaii, United States, 96819
    - Kaiser Permanente - Moanalua Medical Center and Clinic
  - Lihue, Hawaii, United States, 96766
    - Kauai Medical Clinic
  - Wailuku, Hawaii, United States, 96793
    - Maui Memorial Medical Center
  - Wailuku, Hawaii, United States, 96793
    - Pacific Cancer Institute - Maui
- Idaho
  - Boise, Idaho, United States, 83712
    - Mountain States Tumor Institute at St. Luke's Regional Medical Center
  - Boise, Idaho, United States, 83706
    - Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center
- Illinois
  - Aurora, Illinois, United States, 60504
    - Rush-Copley Cancer Care Center
  - Chicago, Illinois, United States, 60637-1470
    - University of Chicago Cancer Research Center
  - Chicago, Illinois, United States, 60611-3013
    - Robert H. Lurie Comprehensive Cancer Center at Northwestern University
  - Chicago, Illinois, United States, 60611
    - Hematology and Oncology Associates
  - Chicago, Illinois, United States, 60657
    - Saint Joseph Hospital
  - Chicago, Illinois, United States, 60657
    - Creticos Cancer Center at Advocate Illinois Masonic Medical Center
  - Chicago, Illinois, United States, 60612-3785
    - John H. Stroger, Jr. Hospital of Cook County
  - Chicago, Illinois, United States, 60631
    - Resurrection Medical Center
  - Decatur, Illinois, United States, 62526
    - Decatur Memorial Hospital Cancer Care Institute
  - Elgin, Illinois, United States, 60123
    - Sherman Hospital
  - Elk Grove Village, Illinois, United States, 60007
    - Alexian Brothers Radiation Oncology
  - Elmhurst, Illinois, United States, 60126
    - Elmhurst Memorial Hospital
  - Evanston, Illinois, United States, 60202
    - St. Francis Hospital
  - Evanston, Illinois, United States, 60201-1781
    - Evanston Hospital
  - Freeport, Illinois, United States, 61032
    - Leonard C. Ferguson Cancer Center
  - Hines, Illinois, United States, 60141
    - Veterans Affairs Medical Center - Hines
  - Joliet, Illinois, United States, 60435
    - Joliet Oncology-Hematology Associates, Limited - West
  - Kankakee, Illinois, United States, 60901
    - Provena St. Mary's Regional Cancer Center - Kankakee
  - La Grange, Illinois, United States, 60525
    - La Grange Memorial Hospital
  - Libertyville, Illinois, United States, 60048
    - North Shore Oncology and Hematology Associates, Limited - Libertyville
  - Moline, Illinois, United States, 61265
    - Trinity Cancer Center at Trinity Medical Center - 7th Street Campus
  - Naperville, Illinois, United States, 60540
    - Edward Hospital Cancer Center
  - Naperville, Illinois, United States, 60540
    - Hematology Oncology Consultants - Naperville
  - Niles, Illinois, United States, 60714
    - Cancer Care and Hematology Specialists of Chicagoland - Niles
  - River Forest, Illinois, United States, 60305
    - West Suburban Center for Cancer Care
  - Rockford, Illinois, United States, 61104-2315
    - Swedish-American Regional Cancer Center
  - Rockford, Illinois, United States, 61108
    - Center for Cancer Care at OSF Saint Anthony Medical Center
  - Skokie, Illinois, United States, 60076
    - Hematology Oncology Associates - Skokie
  - Springfield, Illinois, United States, 62781-0001
    - Regional Cancer Center at Memorial Medical Center
  - Urbana, Illinois, United States, 61801
    - Carle Cancer Center at Carle Foundation Hospital
  - Urbana, Illinois, United States, 61801
    - CCOP - Carle Cancer Center
- Indiana
  - Beech Grove, Indiana, United States, 46107
    - St. Francis Hospital and Health Centers - Beech Grove Campus
  - Elkhart, Indiana, United States, 46515
    - Elkhart General Hospital
  - Elkhart, Indiana, United States, 46514-2098
    - Elkhart Clinic, LLC
  - Elkhart, Indiana, United States, 46514
    - Michiana Hematology-Oncology, PC - Elkhart
  - Fort Wayne, Indiana, United States, 46845
    - Fort Wayne Medical Oncology and Hematology
  - Indianapolis, Indiana, United States, 46260
    - St. Vincent Indianapolis Hospital
  - Kokomo, Indiana, United States, 46904
    - Howard Community Hospital
  - La Porte, Indiana, United States, 46350
    - Center for Cancer Therapy at LaPorte Hospital and Health Services
  - Lafayette, Indiana, United States, 47904
    - Clarian Arnett Cancer Care
  - Merrillville, Indiana, United States, 46410
    - Suniti Medical Corporation
  - Michigan City, Indiana, United States, 46360
    - Saint Anthony Memorial Health Centers
  - Mishawaka, Indiana, United States, 46545-1470
    - Michiana Hematology-Oncology, PC - South Bend
  - Mishawaka, Indiana, United States, 46545-1470
    - Saint Joseph Regional Medical Center
  - Munster, Indiana, United States, 46321
    - Community Hospital
  - Plymouth, Indiana, United States, 46563
    - Michiana Hematology Oncology PC - Plymouth
  - Richmond, Indiana, United States, 47374
    - Reid Hospital & Health Care Services
  - South Bend, Indiana, United States, 46601
    - Memorial Hospital of South Bend
  - South Bend, Indiana, United States, 46601
    - CCOP - Northern Indiana CR Consortium
  - Westville, Indiana, United States, 46391
    - Michiana Hematology Oncology PC - La Porte
- Iowa
  - Ames, Iowa, United States, 50010
    - McFarland Clinic, PC
  - Bettendorf, Iowa, United States, 52722
    - Hematology Oncology Associates of the Quad Cities
  - Cedar Rapids, Iowa, United States, 52403
    - Cedar Rapids Oncology Associates
  - Cedar Rapids, Iowa, United States, 52403
    - Mercy Regional Cancer Center at Mercy Medical Center
  - Council Bluffs, Iowa, United States, 51503
    - Heartland Oncology and Hematology
  - Davenport, Iowa, United States, 52803
    - Genesis Regional Cancer Center at Genesis Medical Center
  - Des Moines, Iowa, United States, 50309
    - CCOP - Iowa Oncology Research Association
  - Des Moines, Iowa, United States, 50309
    - John Stoddard Cancer Center at Iowa Methodist Medical Center
  - Des Moines, Iowa, United States, 50309
    - Medical Oncology and Hematology Associates at John Stoddard Cancer Center
  - Des Moines, Iowa, United States, 50314
    - Medical Oncology and Hematology Associates at Mercy Cancer Center
  - Des Moines, Iowa, United States, 50314
    - Mercy Cancer Center at Mercy Medical Center - Des Moines
  - Des Moines, Iowa, United States, 50316
    - John Stoddard Cancer Center at Iowa Lutheran Hospital
  - Iowa City, Iowa, United States, 52242-1002
    - Holden Comprehensive Cancer Center at University of Iowa
  - Iowa City, Iowa, United States, 52246
    - Veterans Affairs Medical Center - Iowa City
  - Mason City, Iowa, United States, 50401
    - Mercy Cancer Center at Mercy Medical Center - North Iowa
  - Ottumwa, Iowa, United States, 52501
    - McCreery Cancer Center at Ottumwa Regional
  - Sioux City, Iowa, United States, 51101
    - Siouxland Hematology-Oncology Associates, LLP
  - Sioux City, Iowa, United States, 51102
    - Mercy Medical Center - Sioux City
  - Sioux City, Iowa, United States, 51104
    - St. Luke's Regional Medical Center
  - Waterloo, Iowa, United States, 50702
    - Covenant Cancer Treatment Center
- Kansas
  - Hays, Kansas, United States, 67601
    - Hays Medical Center
  - Hutchinson, Kansas, United States, 67502
    - Hutchinson Hospital Corporation
  - Kansas City, Kansas, United States, 66160-7357
    - Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
  - Overland Park, Kansas, United States, 66209
    - Menorah Medical Center
  - Overland Park, Kansas, United States, 66213
    - Saint Luke's Hospital - South
  - Pittsburg, Kansas, United States, 66762
    - Mount Carmel Regional Cancer Center
  - Prairie Village, Kansas, United States, 66208
    - CCOP - Kansas City
  - Salina, Kansas, United States, 67401
    - Tammy Walker Cancer Center at Salina Regional Health Center
  - Topeka, Kansas, United States, 66606
    - Cotton-O'Neil Cancer Center
  - Topeka, Kansas, United States, 66606
    - St. Francis Comprehensive Cancer Center
- Kentucky
  - Lexington, Kentucky, United States, 40536-0093
    - Lucille P. Markey Cancer Center at University of Kentucky
  - Louisville, Kentucky, United States, 40202
    - James Graham Brown Cancer Center at University of Louisville
- Louisiana
  - Alexandria, Louisiana, United States, 71315-3198
    - Tulane Cancer Center Office of Clinical Research
  - Baton Rouge, Louisiana, United States, 70809
    - Ochsner Health Center - Bluebonnet
  - Covington, Louisiana, United States, 70433
    - Ochsner Health Center - Covington
  - New Orleans, Louisiana, United States, 70121
    - CCOP - Ochsner
  - New Orleans, Louisiana, United States, 70121
    - Ochsner Cancer Institute at Ochsner Clinic Foundation
- Maine
  - York, Maine, United States, 03909
    - York Hospital's Oncology Treatment Center
- Maryland
  - Annapolis, Maryland, United States, 21401
    - DeCesaris Cancer Institute at Anne Arundel Medical Center
  - Baltimore, Maryland, United States, 21201
    - Veterans Affairs Medical Center - Baltimore
  - Baltimore, Maryland, United States, 21201
    - Greenebaum Cancer Center at University of Maryland Medical Center
  - Bethesda, Maryland, United States, 20889-5600
    - National Naval Medical Center
  - Easton, Maryland, United States, 21601
    - Shore Regional Cancer Center at Memorial Hospital - Easton
  - Elkton, Maryland, United States, 21921
    - Union Hospital of Cecil County
  - Frederick, Maryland, United States, 21701
    - Frederick Memorial Hospital Regional Cancer Therapy Center
  - Hagerstown, Maryland, United States, 21740
    - John R. Marsh Cancer Center at Washington County Hospital
  - Salisbury, Maryland, United States, 21801
    - Peninsula Regional Medical Center
  - Silver Spring, Maryland, United States, 20910
    - Holy Cross Hospital
- Massachusetts
  - Boston, Massachusetts, United States, 02215
    - Beth Israel Deaconess Medical Center
  - Boston, Massachusetts, United States, 02114
    - Massachusetts General Hospital
  - Boston, Massachusetts, United States, 02118
    - Boston University Cancer Research Center
  - Boston, Massachusetts, United States, 02115
    - Dana-Farber/Brigham and Women's Cancer Center
  - Boston, Massachusetts, United States, 02115
    - Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer Institute
  - Brighton, Massachusetts, United States, 02135-2997
    - Caritas St. Elizabeth's Medical Center
  - Burlington, Massachusetts, United States, 01805
    - Lahey Clinic Medical Center - Burlington
  - Lowell, Massachusetts, United States, 01854
    - Lowell General Hospital
  - Milford, Massachusetts, United States, 01757
    - Dana-Farber/Brigham and Women's Cancer Center at Milford Regional Medical Center
  - Newton, Massachusetts, United States, 02462
    - Newton-Wellesley Hospital
  - Norwood, Massachusetts, United States, 02062
    - Caritas Norwood Hospital
  - Peabody, Massachusetts, United States, 01960
    - NSMC Cancer Center - Peabody
  - Pittsfield, Massachusetts, United States, 01201
    - Berkshire Hematology Oncology, PC
  - Quincy, Massachusetts, United States, 02169
    - Commonwealth Hematology-Oncology, PC - Quincy
  - Springfield, Massachusetts, United States, 01199
    - Baystate Regional Cancer Program at D'Amour Center for Cancer Care
  - Worcester, Massachusetts, United States, 01655
    - UMASS Memorial Cancer Center - University Campus
- Michigan
  - Adrian, Michigan, United States, 49221
    - Hickman Cancer Center at Bixby Medical Center
  - Ann Arbor, Michigan, United States, 48106-0995
    - Saint Joseph Mercy Cancer Center
  - Ann Arbor, Michigan, United States, 48106
    - CCOP - Michigan Cancer Research Consortium
  - Battle Creek, Michigan, United States, 49017
    - Battle Creek Health System Cancer Care Center
  - Big Rapids, Michigan, United States, 49307
    - Mecosta County Medical Center
  - Dearborn, Michigan, United States, 48123-2500
    - Oakwood Cancer Center at Oakwood Hospital and Medical Center
  - Detroit, Michigan, United States, 48201-1379
    - Barbara Ann Karmanos Cancer Institute
  - Escanaba, Michigan, United States, 49431
    - Green Bay Oncology, Limited - Escanaba
  - Flint, Michigan, United States, 48503
    - Hurley Medical Center
  - Flint, Michigan, United States, 48503
    - Genesys Hurley Cancer Institute
  - Grand Rapids, Michigan, United States, 49503
    - Butterworth Hospital at Spectrum Health
  - Grand Rapids, Michigan, United States, 49503
    - CCOP - Grand Rapids
  - Grand Rapids, Michigan, United States, 49503
    - Lacks Cancer Center at Saint Mary's Health Care
  - Grosse Pointe Woods, Michigan, United States, 48236
    - Van Elslander Cancer Center at St. John Hospital and Medical Center
  - Iron Mountain, Michigan, United States, 49801
    - Dickinson County Healthcare System
  - Jackson, Michigan, United States, 49201
    - Foote Memorial Hospital
  - Kalamazoo, Michigan, United States, 49007
    - Bronson Methodist Hospital
  - Kalamazoo, Michigan, United States, 49001
    - Borgess Medical Center
  - Kalamazoo, Michigan, United States, 49007-3731
    - West Michigan Cancer Center
  - Lansing, Michigan, United States, 48912-1811
    - Sparrow Regional Cancer Center
  - Livonia, Michigan, United States, 48154
    - St. Mary Mercy Hospital
  - Monroe, Michigan, United States, 48162
    - Community Cancer Center of Monroe
  - Monroe, Michigan, United States, 48162
    - Mercy Memorial Hospital - Monroe
  - Mount Clemens, Michigan, United States, 48043
    - Clemens Regional Medical Center
  - Muskegon, Michigan, United States, 49443
    - Mercy General Health Partners
  - Niles, Michigan, United States, 49120
    - Michiana Hematology Oncology PC - Niles
  - Petoskey, Michigan, United States, 49770
    - Northern Michigan Hospital
  - Pontiac, Michigan, United States, 48341-2985
    - St. Joseph Mercy Oakland
  - Port Huron, Michigan, United States, 48060
    - Mercy Regional Cancer Center at Mercy Hospital
  - Royal Oak, Michigan, United States, 48073
    - William Beaumont Hospital - Royal Oak Campus
  - Saginaw, Michigan, United States, 48601
    - Seton Cancer Institute at Saint Mary's - Saginaw
  - Saint Joseph, Michigan, United States, 49085
    - Lakeside Cancer Specialists, PLLC
  - Saint Joseph, Michigan, United States, 49085
    - Lakeland Regional Cancer Care Center - St. Joseph
  - Southfield, Michigan, United States, 48075
    - Providence Cancer Institute at Providence Hospital - Southfield Campus
  - Traverse City, Michigan, United States, 49684
    - Munson Medical Center
  - Warren, Michigan, United States, 48093
    - St. John Macomb Hospital
  - Wyoming, Michigan, United States, 49519
    - Metro Health Hospital
- Minnesota
  - Alexandria, Minnesota, United States, 56308
  - Bemidji, Minnesota, United States, 56601
    - MeritCare Bemidji
  - Brainerd, Minnesota, United States, 56401
    - St. Joseph's Medical Center
  - Burnsville, Minnesota, United States, 55337
    - Fairview Ridges Hospital
  - Coon Rapids, Minnesota, United States, 55433
    - Mercy and Unity Cancer Center at Mercy Hospital
  - Duluth, Minnesota, United States, 55805
    - CCOP - Duluth
  - Duluth, Minnesota, United States, 55805-1983
    - Duluth Clinic Cancer Center - Duluth
  - Duluth, Minnesota, United States, 55805
    - Miller - Dwan Medical Center
  - Duluth, Minnesota, United States, 55805
    - St. Luke's Hospital Cancer Care Center
  - Edina, Minnesota, United States, 55435
    - Fairview Southdale Hospital
  - Fridley, Minnesota, United States, 55432
    - Mercy and Unity Cancer Center at Unity Hospital
  - Hutchinson, Minnesota, United States, 55350
    - Hutchinson Area Health Care
  - Mankato, Minnesota, United States, 56002
    - Immanuel St. Joseph's
  - Maplewood, Minnesota, United States, 55109
    - Minnesota Oncology Hematology, PA - Maplewood
  - Maplewood, Minnesota, United States, 55109
    - HealthEast Cancer Care at St. John's Hospital
  - Minneapolis, Minnesota, United States, 55417
    - Veterans Affairs Medical Center - Minneapolis
  - Minneapolis, Minnesota, United States, 55407
    - Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
  - Minneapolis, Minnesota, United States, 55415
    - Hennepin County Medical Center - Minneapolis
  - Robbinsdale, Minnesota, United States, 55422-2900
    - Humphrey Cancer Center at North Memorial Outpatient Center
  - Saint Cloud, Minnesota, United States, 56303
    - CentraCare Clinic - River Campus
  - Saint Cloud, Minnesota, United States, 56303
    - Coborn Cancer Center
  - Saint Louis Park, Minnesota, United States, 55416
    - CCOP - Metro-Minnesota
  - Saint Louis Park, Minnesota, United States, 55416
    - Park Nicollet Cancer Center
  - Saint Paul, Minnesota, United States, 55102
    - United Hospital
  - Saint Paul, Minnesota, United States, 55101
    - Regions Hospital Cancer Care Center
  - Shakopee, Minnesota, United States, 55379
    - St. Francis Cancer Center at St. Francis Medical Center
  - Stillwater, Minnesota, United States, 55082
    - Lakeview Hospital
  - Waconia, Minnesota, United States, 55387
    - Ridgeview Medical Center
  - Willmar, Minnesota, United States, 56201
    - Willmar Cancer Center at Rice Memorial Hospital
  - Woodbury, Minnesota, United States, 55125
    - Minnesota Oncology Hematology, PA - Woodbury
- Mississippi
  - Jackson, Mississippi, United States, 39216
    - University of Mississippi Cancer Clinic
  - Keesler Air Force Base, Mississippi, United States, 39534
    - Keesler Air Force Base Medical Center
  - Pascagoula, Mississippi, United States, 39581
    - Regional Cancer Center at Singing River Hospital
- Missouri
  - Bolivar, Missouri, United States, 65613
    - Central Care Cancer Center at Carrie J. Babb Cancer Center
  - Branson, Missouri, United States, 65616
    - Skaggs Cancer Center at Skaggs Regional Medical Center
  - Cape Girardeau, Missouri, United States, 63703
    - Southeast Cancer Center
  - Columbia, Missouri, United States, 65203
    - Ellis Fischel Cancer Center at University of Missouri - Columbia
  - Jefferson City, Missouri, United States, 65109
    - Goldschmidt Cancer Center
  - Kansas City, Missouri, United States, 64128
    - Veterans Affairs Medical Center - Kansas City
  - Kansas City, Missouri, United States, 64116
    - North Kansas City Hospital
  - Kansas City, Missouri, United States, 64132
    - Research Medical Center
  - Kansas City, Missouri, United States, 64108
    - Truman Medical Center - Hospital Hill
  - Kansas City, Missouri, United States, 64111
    - Saint Luke's Cancer Institute at Saint Luke's Hospital
  - Kansas City, Missouri, United States, 64114
    - St. Joseph Medical Center
  - Kansas City, Missouri, United States, 64116
    - Parvin Radiation Oncology
  - Kansas City, Missouri, United States, 64118
    - Heartland Hematology Oncology Associates, Incorporated
  - Lee's Summit, Missouri, United States, 64086
    - Saint Luke's East - Lee's Summit
  - Saint Joseph, Missouri, United States, 64506
    - Heartland Regional Medical Center
  - Saint Joseph, Missouri, United States, 64507
    - Saint Joseph Oncology, Incorporated
  - Saint Louis, Missouri, United States, 63131
    - Missouri Baptist Cancer Center
  - Saint Louis, Missouri, United States, 63110
    - Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
  - Saint Louis, Missouri, United States, 63110
    - Saint Louis University Cancer Center
  - Saint Louis, Missouri, United States, 63141
    - Comprehensive Cancer Care, PC
  - Springfield, Missouri, United States, 65802
    - CCOP - Cancer Research for the Ozarks
  - Springfield, Missouri, United States, 65804
    - St. John's Regional Health Center
  - Springfield, Missouri, United States, 65807
    - Hulston Cancer Center at Cox Medical Center South
- Montana
  - Billings, Montana, United States, 59101
    - CCOP - Montana Cancer Consortium
  - Billings, Montana, United States, 59101
    - St. Vincent Healthcare Cancer Care Services
  - Billings, Montana, United States, 59107-7000
    - Billings Clinic - Downtown
  - Billings, Montana, United States, 59102
    - Hematology-Oncology Centers of the Northern Rockies - Billings
  - Bozeman, Montana, United States, 59715
    - Bozeman Deaconess Cancer Center
  - Butte, Montana, United States, 59701
    - St. James Healthcare Cancer Care
  - Great Falls, Montana, United States, 59405
    - Great Falls Clinic - Main Facility
  - Great Falls, Montana, United States, 59405-5309
    - Big Sky Oncology
  - Great Falls, Montana, United States, 59405
    - Sletten Cancer Institute at Benefis Healthcare
  - Havre, Montana, United States, 59501
    - Northern Montana Hospital
  - Helena, Montana, United States, 59601
    - St. Peter's Hospital
  - Kalispell, Montana, United States, 59901
    - Kalispell Regional Medical Center
  - Kalispell, Montana, United States, 59901
    - Glacier Oncology, PLLC
  - Kalispell, Montana, United States, 59901
    - Kalispell Medical Oncology at KRMC
  - Missoula, Montana, United States, 59807-7877
    - Montana Cancer Specialists at Montana Cancer Center
  - Missoula, Montana, United States, 59807
    - Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
- Nebraska
  - Grand Island, Nebraska, United States, 68803
    - Saint Francis Cancer Treatment Center at Saint Francis Memorial Health Center
  - Kearney, Nebraska, United States, 68848-1990
    - Good Samaritan Cancer Center at Good Samaritan Hospital
  - Lincoln, Nebraska, United States, 68510
    - Cancer Resource Center - Lincoln
  - North Platte, Nebraska, United States, 69103
    - Callahan Cancer Center at Great Plains Regional Medical Center
  - Omaha, Nebraska, United States, 68198-6805
    - UNMC Eppley Cancer Center at the University of Nebraska Medical Center
  - Omaha, Nebraska, United States, 68106
    - CCOP - Missouri Valley Cancer Consortium
  - Omaha, Nebraska, United States, 68122
    - Immanuel Medical Center
  - Omaha, Nebraska, United States, 68124
    - Alegant Health Cancer Center at Bergan Mercy Medical Center
  - Omaha, Nebraska, United States, 68131-2197
    - Creighton University Medical Center
  - Omaha, Nebraska, United States, 68114
    - Methodist Estabrook Cancer Center
  - Omaha, Nebraska, United States, 68130
    - Lakeside Hospital
- Nevada
  - Las Vegas, Nevada, United States, 89102
    - University Medical Center of Southern Nevada
  - Las Vegas, Nevada, United States, 89135
    - Nevada Cancer Institute
  - Las Vegas, Nevada, United States, 89106
    - CCOP - Nevada Cancer Research Foundation
- New Hampshire
  - Concord, New Hampshire, United States, 03301
    - New Hampshire Oncology - Hematology, PA at Payson Center for Cancer Care
  - Exeter, New Hampshire, United States, 03833
    - Center for Cancer Care at Exeter Hospital
  - Hooksett, New Hampshire, United States, 03106
    - New Hampshire Oncology - Hematology, PA - Hooksett
  - Laconia, New Hampshire, United States, 03246
    - Lakes Region General Hospital
  - Lebanon, New Hampshire, United States, 03756-0002
    - Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
  - Manchester, New Hampshire, United States, 03103
    - Elliot Regional Cancer Center at Elliot Hospital
  - Manchester, New Hampshire, United States, 03102
    - Norris Cotton Cancer Center at Catholic Medical Center
  - Nashua, New Hampshire, United States, 03060
    - Oncology Center at St. Joseph Hospital
- New Jersey
  - East Orange, New Jersey, United States, 07018-1095
    - Veterans Affairs Medical Center - East Orange
  - Englewood, New Jersey, United States, 07631
    - Dizzy Gillespie Cancer Institute at Englewood Hospital and Medical Center
  - Flemington, New Jersey, United States, 08822
    - Hunterdon Regional Cancer Center at Hunterdon Medical Center
  - Freehold, New Jersey, United States, 07728
    - CentraState Medical Center
  - Marlton, New Jersey, United States, 08053
    - Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton
  - Morristown, New Jersey, United States, 07962
    - Carol G. Simon Cancer Center at Morristown Memorial Hospital
  - Newark, New Jersey, United States, 07112
    - Newark Beth Israel Medical Center
  - Newark, New Jersey, United States, 07103
    - UMDNJ University Hospital
  - Ridgewood, New Jersey, United States, 07450
    - Valley Hospital - Ridgewood
  - Somerville, New Jersey, United States, 08876
    - Somerset Medical Center
  - Sparta, New Jersey, United States, 07871
    - Frederick R. and Betty M. Smith Cancer Treatment Center
  - Summit, New Jersey, United States, 07902
    - Overlook Hospital
  - Voorhees, New Jersey, United States, 08043
    - Cancer Institute of New Jersey at Cooper - Voorhees
  - Voorhees, New Jersey, United States, 08043
    - Fox Chase Virtua Health Cancer Program at Virtua West Jersey
- New York
  - Buffalo, New York, United States, 14215
    - Veterans Affairs Medical Center - Buffalo
  - East Syracuse, New York, United States, 13057
    - CCOP - Hematology-Oncology Associates of Central New York
  - Elmira, New York, United States, 14905
    - Falck Cancer Center at Arnot Ogden Medical Center
  - Jamaica, New York, United States, 11432
    - Queens Cancer Center of Queens Hospital
  - Manhasset, New York, United States, 11030
    - CCOP - North Shore University Hospital
  - Manhasset, New York, United States, 11030
    - Don Monti Comprehensive Cancer Center at North Shore University Hospital
  - Middletown, New York, United States, 10940-4199
    - Tucker Center for Cancer Care at Orange Regional Medical Center
  - Mineola, New York, United States, 11501
    - Winthrop University Hospital
  - Mount Kisco, New York, United States, 10549-3417
    - Mount Kisco Medical Group, PC
  - New Hyde Park, New York, United States, 11040
    - Long Island Jewish Medical Center
  - Rochester, New York, United States, 14642
    - James P. Wilmot Cancer Center at University of Rochester Medical Center
  - Rochester, New York, United States, 14623
    - Interlakes Oncology/Hematology PC
  - Staten Island, New York, United States, 10305
    - Nalitt Cancer Institute at Staten Island University Hospital
  - Syracuse, New York, United States, 13210
    - Veterans Affairs Medical Center - Syracuse
  - Syracuse, New York, United States, 13210
    - SUNY Upstate Medical University Hospital
  - Utica, New York, United States, 13502
    - Faxton Regional Cancer Center
- North Carolina
  - Asheboro, North Carolina, United States, 27203-5400
    - Randolph Hospital
  - Asheville, North Carolina, United States, 28801
    - Mission Hospitals - Memorial Campus
  - Burlington, North Carolina, United States, 27216
    - Alamance Cancer Center at Alamance Regional Medical Center
  - Cary, North Carolina, United States, 27518
    - Waverly Hematology Oncology
  - Chapel Hill, North Carolina, United States, 27599-7295
    - Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
  - Charlotte, North Carolina, United States, 28232-2861
    - Blumenthal Cancer Center at Carolinas Medical Center
  - Charlotte, North Carolina, United States, 28233-3549
    - Presbyterian Cancer Center at Presbyterian Hospital
  - Concord, North Carolina, United States, 28025
    - Batte Cancer Center at Northeast Medical Center
  - Gastonia, North Carolina, United States, 28053
    - CaroMont Cancer Center at Gaston Memorial Hospital
  - Goldsboro, North Carolina, United States, 27534
    - Wayne Memorial Hospital, Incorporated
  - Greensboro, North Carolina, United States, 27403-1198
    - Moses Cone Regional Cancer Center at Wesley Long Community Hospital
  - Hendersonville, North Carolina, United States, 28791
    - Pardee Memorial Hospital
  - Kinston, North Carolina, United States, 28501
    - Kinston Medical Specialists
  - Pinehurst, North Carolina, United States, 28374
    - FirstHealth Moore Regional Community Hospital Comprehensive Cancer Center
  - Raleigh, North Carolina, United States, 27607
    - Rex Cancer Center at Rex Hospital
  - Reidsville, North Carolina, United States, 27320
    - Annie Penn Cancer Center
  - Rocky Mount, North Carolina, United States, 27804
    - Nash Hospitals, Incorporated
  - Rutherfordton, North Carolina, United States, 28139
    - Rutherford Hospital
  - Statesville, North Carolina, United States, 28677
    - Iredell Memorial Hospital
  - Washington, North Carolina, United States, 27889
    - Marion L. Shepard Cancer Center at Beaufort County Hospital
  - Wilmington, North Carolina, United States, 28401
    - Zimmer Cancer Center at New Hanover Regional Medical Center
  - Winston-Salem, North Carolina, United States, 27157-1096
    - Wake Forest University Comprehensive Cancer Center
- North Dakota
  - Bismarck, North Dakota, United States, 58501
    - Bismarck Cancer Center
  - Bismarck, North Dakota, United States, 58501
    - Medcenter One Hospital Cancer Care Center
  - Bismarck, North Dakota, United States, 58501
    - Mid Dakota Clinic, PC
  - Bismarck, North Dakota, United States, 58502
    - St. Alexius Medical Center Cancer Center
  - Fargo, North Dakota, United States, 58122
    - CCOP - MeritCare Hospital
  - Fargo, North Dakota, United States, 58102
    - MeritCare Broadway
  - Fargo, North Dakota, United States, 58122
    - Roger Maris Cancer Center at MeritCare Hospital
  - Grand Forks, North Dakota, United States, 58201
    - Altru Cancer Center at Altru Hospital
  - Minot, North Dakota, United States, 58701
    - Trinity Cancercare Center
- Ohio
  - Akron, Ohio, United States, 44307
    - McDowell Cancer Center at Akron General Medical Center
  - Bowling Green, Ohio, United States, 43402
    - Wood County Oncology Center
  - Canton, Ohio, United States, 44708
    - Mercy Cancer Center at Mercy Medical Center
  - Chillicothe, Ohio, United States, 45601
    - Adena Regional Medical Center
  - Cleveland, Ohio, United States, 44195
    - Cleveland Clinic Taussig Cancer Center
  - Cleveland, Ohio, United States, 44109
    - MetroHealth Cancer Care Center at MetroHealth Medical Center
  - Columbus, Ohio, United States, 43214-3998
    - Riverside Methodist Hospital Cancer Care
  - Columbus, Ohio, United States, 43222
    - Mount Carmel Health - West Hospital
  - Columbus, Ohio, United States, 43215
    - CCOP - Columbus
  - Columbus, Ohio, United States, 43215
    - Grant Medical Center Cancer Care
  - Columbus, Ohio, United States, 43228
    - Doctors Hospital at Ohio Health
  - Columbus, Ohio, United States, 43210-1240
    - Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center
  - Columbus, Ohio, United States, 43219
    - Zangmeister Center
  - Columbus, Ohio, United States, 43213
    - Mount Carmel Hospital East
  - Dayton, Ohio, United States, 45405
    - Grandview Hospital
  - Dayton, Ohio, United States, 45406
    - Good Samaritan Hospital
  - Dayton, Ohio, United States, 45409
    - David L. Rike Cancer Center at Miami Valley Hospital
  - Dayton, Ohio, United States, 45415
    - Samaritan North Cancer Care Center
  - Dayton, Ohio, United States, 45420
    - CCOP - Dayton
  - Delaware, Ohio, United States, 43015
    - Grady Memorial Hospital
  - Elyria, Ohio, United States, 44035
    - Community Cancer Center
  - Elyria, Ohio, United States, 44035
    - Hematology Oncology Center
  - Findlay, Ohio, United States, 45840
    - Blanchard Valley Medical Associates
  - Franklin, Ohio, United States, 45005-1066
    - Middletown Regional Hospital
  - Greenville, Ohio, United States, 45331
    - Wayne Hospital
  - Kettering, Ohio, United States, 45429
    - Charles F. Kettering Memorial Hospital
  - Lancaster, Ohio, United States, 43130
    - Fairfield Medical Center
  - Lima, Ohio, United States, 45804
    - Lima Memorial Hospital
  - Lima, Ohio, United States, 45801
    - St. Rita's Medical Center
  - Mansfield, Ohio, United States, 44903
    - MedCentral - Mansfield Hospital
  - Marietta, Ohio, United States, 45750
    - Strecker Cancer Center at Marietta Memorial Hospital
  - Maumee, Ohio, United States, 43537-1839
    - Northwest Ohio Oncology Center
  - Mayfield Heights, Ohio, United States, 44124
    - Hillcrest Cancer Center at Hillcrest Hospital
  - Mount Vernon, Ohio, United States, 43050
    - Knox Community Hospital
  - Newark, Ohio, United States, 43055
    - Licking Memorial Cancer Care Program at Licking Memorial Hospital
  - Norwalk, Ohio, United States, 44857
    - Fisher-Titus Medical Center
  - Oregon, Ohio, United States, 43616
    - St. Charles Mercy Hospital
  - Oregon, Ohio, United States, 43616
    - Toledo Clinic - Oregon
  - Portsmouth, Ohio, United States, 45662
    - Southern Ohio Medical Center Cancer Center
  - Sandusky, Ohio, United States, 44870
    - North Coast Cancer Care, Incorporated
  - Springfield, Ohio, United States, 45505
    - Community Hospital of Springfield and Clark County
  - Sylvania, Ohio, United States, 43560
    - Flower Hospital Cancer Center
  - Tiffin, Ohio, United States, 44883
    - Mercy Hospital of Tiffin
  - Toledo, Ohio, United States, 43608
    - St. Vincent Mercy Medical Center
  - Toledo, Ohio, United States, 43606
    - Toledo Hospital
  - Toledo, Ohio, United States, 43614
    - Medical University of Ohio Cancer Center
  - Toledo, Ohio, United States, 43617
    - CCOP - Toledo Community Hospital
  - Toledo, Ohio, United States, 43623
    - Toledo Clinic, Incorporated - Main Clinic
  - Toledo, Ohio, United States, 43623
    - St. Anne Mercy Hospital
  - Troy, Ohio, United States, 45373-1300
    - UVMC Cancer Care Center at Upper Valley Medical Center
  - Wauseon, Ohio, United States, 43567
    - Fulton County Health Center
  - Westerville, Ohio, United States, 43081
    - Mount Carmel St. Ann's Cancer Center
  - Wooster, Ohio, United States, 44691
    - Cleveland Clinic - Wooster
  - Wright-Patterson Air Force Base, Ohio, United States, 45433-5529
    - United States Air Force Medical Center - Wright-Patterson
  - Xenia, Ohio, United States, 45385
    - Ruth G. McMillan Cancer Center at Greene Memorial Hospital
  - Zanesville, Ohio, United States, 43701
    - Genesis - Good Samaritan Hospital
- Oklahoma
  - Lawton, Oklahoma, United States, 73505
    - Cancer Centers of Southwest Oklahoma, LLC - Lawton
  - Norman, Oklahoma, United States, 73071
    - Cancer Care Associates - Norman
  - Oklahoma City, Oklahoma, United States, 73104
    - Oklahoma University Cancer Institute
  - Oklahoma City, Oklahoma, United States, 73120
    - Cancer Care Associates - Mercy Campus
  - Oklahoma City, Oklahoma, United States, 73120
    - Cancer Care Associates at Troy and Dollie Smith Cancer Center
- Oregon
  - Clackamas, Oregon, United States, 97015
    - Clackamas Radiation Oncology Center
  - Milwaukie, Oregon, United States, 97222
    - Providence Milwaukie Hospital
  - Newberg, Oregon, United States, 97132
    - Providence Newberg Medical Center
  - Oregon City, Oregon, United States, 97045
    - Willamette Falls Hospital
  - Portland, Oregon, United States, 97239-3098
    - Knight Cancer Institute At Oregon Health and Science University
  - Portland, Oregon, United States, 97213-2967
    - Providence Cancer Center at Providence Portland Medical Center
  - Portland, Oregon, United States, 97225
    - CCOP - Columbia River Oncology Program
  - Portland, Oregon, United States, 97225
    - Providence St. Vincent Medical Center
  - Portland, Oregon, United States, 97227
    - Kaiser Permanente Health Care - Portland
  - The Dalles, Oregon, United States, 97058
    - Celilo Cancer Center at Mid-Columbia Medical Center
- Pennsylvania
  - Abington, Pennsylvania, United States, 19001
    - Rosenfeld Cancer Center at Abington Memorial Hospital
  - Allentown, Pennsylvania, United States, 18105
    - Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest
  - Bethlehem, Pennsylvania, United States, 18015
    - St. Luke's Cancer Network at St. Luke's Hospital
  - Bryn Mawr, Pennsylvania, United States, 19010
    - Bryn Mawr Hospital
  - Danville, Pennsylvania, United States, 17822-0001
    - Geisinger Cancer Institute at Geisinger Health
  - Darby, Pennsylvania, United States, 19023
    - Mercy Fitzgerald Hospital
  - Doylestown, Pennsylvania, United States, 18901
    - Doylestown Hospital Cancer Center
  - Drexel Hill, Pennsylvania, United States, 19026
    - Delaware County Regional Cancer Center at Delaware County Memorial Hospital
  - East Stroudsburg, Pennsylvania, United States, 18301
    - Dale and Frances Hughes Cancer Center at Pocono Medical Center
  - Ephrata, Pennsylvania, United States, 17522
    - Ephrata Cancer Center at Ephrata Community Hospital
  - Hazleton, Pennsylvania, United States, 18201
    - Geisinger Hazleton Cancer Center
  - Media, Pennsylvania, United States, 19063
    - Riddle Memorial Hospital Cancer Center
  - Paoli, Pennsylvania, United States, 19301-1792
    - Cancer Center of Paoli Memorial Hospital
  - Philadelphia, Pennsylvania, United States, 19104-4283
    - Abramson Cancer Center of the University of Pennsylvania
  - Philadelphia, Pennsylvania, United States, 19107-5541
    - Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
  - Pittsburgh, Pennsylvania, United States, 15224-1791
    - Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital
  - Pottstown, Pennsylvania, United States, 19464
    - Pottstown Memorial Regional Cancer Center
  - Reading, Pennsylvania, United States, 19605
    - St. Joseph Medical Center
  - Reading, Pennsylvania, United States, 19612-6052
    - McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center
  - Sayre, Pennsylvania, United States, 18840
    - Guthrie Cancer Center at Guthrie Clinic Sayre
  - Scranton, Pennsylvania, United States, 18508
    - Hematology and Oncology Associates of Northeastern Pennsylvania
  - Sellersville, Pennsylvania, United States, 18960
    - Grand View Hospital
  - State College, Pennsylvania, United States, 16803
    - Mount Nittany Medical Center
  - State College, Pennsylvania, United States, 16801
    - Geisinger Medical Group - Scenery Park
  - Upland, Pennsylvania, United States, 19013
    - Associates in Hematology-Oncology, PC at Crozer Regional Cancer Center
  - West Grove, Pennsylvania, United States, 19390-9499
    - Jennersville Regional Hospital
  - Wilkes-Barre, Pennsylvania, United States, 18711
    - Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center
  - Wynnewood, Pennsylvania, United States, 19096
    - Lankenau Cancer Center at Lankenau Hospital
  - Wynnewood, Pennsylvania, United States, 19096
    - CCOP - Main Line Health
  - York, Pennsylvania, United States, 17405
    - York Cancer Center at Apple Hill Medical Center
- Rhode Island
  - Pawtucket, Rhode Island, United States, 02860
    - Memorial Hospital of Rhode Island
  - Warwick, Rhode Island, United States, 02886
    - Kent County Memorial Hospital
- South Carolina
  - Anderson, South Carolina, United States, 29621
    - AnMed Cancer Center
  - Beaufort, South Carolina, United States, 29902
    - Keyserling Cancer Center at Beaufort Memorial Hospital
  - Florence, South Carolina, United States, 29501
    - McLeod Regional Medical Center
  - Spartanburg, South Carolina, United States, 29303
    - CCOP - Upstate Carolina
  - Spartanburg, South Carolina, United States, 29303
    - Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
- South Dakota
  - Rapid City, South Dakota, United States, 57701
    - Rapid City Regional Hospital
  - Sioux Falls, South Dakota, United States, 57105
    - Avera Cancer Institute
  - Sioux Falls, South Dakota, United States, 57105
    - Medical X-Ray Center, PC
  - Sioux Falls, South Dakota, United States, 57117-5039
    - Sanford Cancer Center at Sanford USD Medical Center
- Tennessee
  - Kingsport, Tennessee, United States, 37662
    - Christine LaGuardia Phillips Cancer Center at Wellmont Holston Valley Medical Center
  - Knoxville, Tennessee, United States, 37916
    - Thompson Cancer Survival Center
  - Memphis, Tennessee, United States, 38104
    - University of Tennessee Cancer Institute - Memphis
  - Nashville, Tennessee, United States, 37208-3599
    - MBCCOP - Meharry Medical College - Nashville
- Texas
  - Amarillo, Texas, United States, 79106
    - Harrington Cancer Center
  - Austin, Texas, United States, 78701
    - Seton Shivers Cancer Program at Brackenridge Hospital
  - Fort Sam Houston, Texas, United States, 78234-6200
    - Brooke Army Medical Center
  - Houston, Texas, United States, 77030
    - Ben Taub General Hospital
  - Houston, Texas, United States, 77030
    - Veterans Affairs Medical Center - Houston
  - Houston, Texas, United States, 77030
    - Baylor University Medical Center - Houston
  - Houston, Texas, United States, 77030
    - St. Luke's Texas Cancer Institute at St. Luke's Episcopal Hospital
  - Lackland Air Force Base, Texas, United States, 78236
    - Wilford Hall Medical Center
  - Lubbock, Texas, United States, 79415-3364
    - UMC Southwest Cancer and Research Center
  - San Antonio, Texas, United States, 78229
    - Cancer Therapy and Research Center
  - San Antonio, Texas, United States, 78209
    - Veterans Affairs Medical Center - San Antonio (Murphy)
  - San Antonio, Texas, United States, 78229-3900
    - University of Texas Health Science Center at San Antonio
  - Temple, Texas, United States, 76508
    - CCOP - Scott and White Hospital
- Utah
  - American Fork, Utah, United States, 84003
    - American Fork Hospital
  - Cedar City, Utah, United States, 84720
    - Sandra L. Maxwell Cancer Center
  - Logan, Utah, United States, 84321
    - Logan Regional Hospital
  - Murray, Utah, United States, 84157
    - Jon and Karen Huntsman Cancer Center at Intermountain Medical Center
  - Ogden, Utah, United States, 84403
    - Val and Ann Browning Cancer Center at McKay-Dee Hospital Center
  - Provo, Utah, United States, 84604
    - Utah Valley Regional Medical Center - Provo
  - Saint George, Utah, United States, 84770
    - Dixie Regional Medical Center - East Campus
  - Salt Lake City, Utah, United States, 84143
    - LDS Hospital
  - Salt Lake City, Utah, United States, 84106
    - Utah Cancer Specialists at UCS Cancer Center
- Vermont
  - Berlin, Vermont, United States, 05602
    - Mountainview Medical
  - Burlington, Vermont, United States, 05401
    - Fletcher Allen Health Care - University Health Center Campus
- Virginia
  - Charlottesville, Virginia, United States, 22908
    - University of Virginia Cancer Center
  - Danville, Virginia, United States, 24541
    - Danville Regional Medical Center
  - Fredericksburg, Virginia, United States, 22401
    - Fredericksburg Oncology, Incorporated
  - Hampton, Virginia, United States, 23666
    - Virginia Oncology Associates - Hampton
  - Lynchburg, Virginia, United States, 24501
    - Lynchburg Hematology-Oncology Clinic
  - Norton, Virginia, United States, 24273
    - Southwest Virginia Regional Cancer Center at Wellmonth Health
  - Richmond, Virginia, United States, 23298-0037
    - Virginia Commonwealth University Massey Cancer Center
  - Richmond, Virginia, United States, 23230
    - Virginia Cancer Institute - West End
- Washington
  - Anacortes, Washington, United States, 98221
    - Island Hospital Cancer Care Center at Island Hospital
  - Bellingham, Washington, United States, 98225
    - St. Joseph Cancer Center
  - Bremerton, Washington, United States, 98310
    - Olympic Hematology and Oncology
  - Burien, Washington, United States, 98166
    - Highline Medical Center Cancer Center
  - Centralia, Washington, United States, 98531-9027
    - Providence Centralia Hospital
  - Federal Way, Washington, United States, 98003
    - St. Francis Hospital
  - Kennewick, Washington, United States, 99336
    - Columbia Basin Hematology
  - Mount Vernon, Washington, United States, 98274
    - Skagit Valley Hospital Cancer Care Center
  - Olympia, Washington, United States, 98506-5166
    - Providence St. Peter Hospital Regional Cancer Center
  - Poulsbo, Washington, United States, 98370
    - Harrison Poulsbo Hematology and Onocology
  - Puyallup, Washington, United States, 98372
    - Good Samaritan Cancer Center
  - Seattle, Washington, United States, 98104
    - Minor and James Medical, PLLC
  - Seattle, Washington, United States, 98112
    - Group Health Central Hospital
  - Seattle, Washington, United States, 98122-4307
    - Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
  - Seattle, Washington, United States, 98195
    - University Cancer Center at University of Washington Medical Center
  - Sedro-Woolley, Washington, United States, 98284
    - North Puget Oncology at United General Hospital
  - Spokane, Washington, United States, 99202
    - Cancer Care Northwest - Spokane South
  - Spokane, Washington, United States, 99218
    - Evergreen Hematology and Oncology, PS
  - Spokane, Washington, United States, 99204-2967
    - Rockwood Clinic Cancer Treatment Center
  - Tacoma, Washington, United States, 98405-3004
    - Franciscan Cancer Center at St. Joseph Medical Center
  - Tacoma, Washington, United States, 98405
    - Allenmore Hospital
  - Tacoma, Washington, United States, 98405
    - CCOP - Northwest
  - Tacoma, Washington, United States, 98405
    - MultiCare Regional Cancer Center at Tacoma General Hospital
  - Tacoma, Washington, United States, 98499
    - St. Clare Hospital
  - Vancouver, Washington, United States, 98664
    - Southwest Washington Medical Center Cancer Center
  - Wenatchee, Washington, United States, 98801-2028
    - Wenatchee Valley Medical Center
- West Virginia
  - Charleston, West Virginia, United States, 25304
    - West Virginia University Health Sciences Center - Charleston
  - Huntington, West Virginia, United States, 25701
    - Edwards Comprehensive Cancer Center at Cabell Huntington Hospital
  - Parkersburg, West Virginia, United States, 26102
    - Community Comprehensive Cancer Center at Camden-Clark Memorial Hospital
  - Princeton, West Virginia, United States, 24740
    - Princeton Community Hospital
- Wisconsin
  - Antigo, Wisconsin, United States, 54409
    - Langlade Memorial Hospital
  - Appleton, Wisconsin, United States, 54911-3496
    - Fox Valley Hematology and Oncology - East Grant Street
  - Chippewa Falls, Wisconsin, United States, 54729
    - Marshfield Clinic - Chippewa Center
  - Eau Claire, Wisconsin, United States, 54701
    - Marshfield Clinic Cancer Care at Regional Cancer Center
  - Green Bay, Wisconsin, United States, 54307-3508
    - St. Vincent Hospital Regional Cancer Center
  - Green Bay, Wisconsin, United States, 54301-3526
    - Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center
  - Green Bay, Wisconsin, United States, 54303
    - Green Bay Oncology, Limited at St. Mary's Hospital
  - Green Bay, Wisconsin, United States, 54303
    - St. Mary's Hospital Medical Center - Green Bay
  - Green Bay, Wisconsin, United States, 54311
    - Vince Lombardi Cancer Clinic - Green Bay at Aurora BayCare Medical Center
  - Janesville, Wisconsin, United States, 53547
    - Mercy Regional Cancer Center
  - Johnson Creek, Wisconsin, United States, 53038
    - UW Cancer Center Johnson Creek
  - La Crosse, Wisconsin, United States, 54601
    - Gundersen Lutheran Center for Cancer and Blood
  - La Crosse, Wisconsin, United States, 54601
    - Franciscan Skemp Healthcare - La Crosse Campus
  - Madison, Wisconsin, United States, 53792-6164
    - University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
  - Madison, Wisconsin, United States, 53717
    - Dean Medical Center - Madison
  - Manitowoc, Wisconsin, United States, 54221-1450
    - Holy Family Memorial Medical Center Cancer Care Center
  - Marinette, Wisconsin, United States, 54143
    - Bay Area Cancer Care Center at Bay Area Medical Center
  - Marinette, Wisconsin, United States, 54143
    - Vince Lombardi Cancer Clinic - Marinette
  - Marshfield, Wisconsin, United States, 54449
    - Saint Joseph's Hospital
  - Marshfield, Wisconsin, United States, 54449
    - Marshfield Clinic - Marshfield Center
  - Minocqua, Wisconsin, United States, 54548
    - Marshfield Clinic - Lakeland Center
  - Mukwonago, Wisconsin, United States, 53149
    - D.N. Greenwald Center
  - Oconomowoc, Wisconsin, United States, 53066
    - Regional Cancer Center at Oconomowoc Memorial Hospital
  - Oconto Falls, Wisconsin, United States, 54154
    - Green Bay Oncology, Limited - Oconto Falls
  - Oshkosh, Wisconsin, United States, 54904
    - Vince Lombardi Cancer Clinic - Oshkosh
  - Racine, Wisconsin, United States, 53405
    - All Saints Cancer Center at Wheaton Franciscan Healthcare
  - Rhinelander, Wisconsin, United States, 54501
    - Ministry Medical Group at Saint Mary's Hospital
  - Rice Lake, Wisconsin, United States, 54868
    - Marshfield Clinic - Indianhead Center
  - Sheboygan, Wisconsin, United States, 53081
    - St. Nicholas Hospital
  - Stevens Point, Wisconsin, United States, 54481
    - Saint Michael's Hospital Cancer Center
  - Sturgeon Bay, Wisconsin, United States, 54235
    - Green Bay Oncology, Limited - Sturgeon Bay
  - Summit, Wisconsin, United States, 53066
    - Aurora Medical Center
  - Two Rivers, Wisconsin, United States, 54241
    - Vince Lombardi Cancer Clinic - Two Rivers
  - Waukesha, Wisconsin, United States, 53188
    - Waukesha Memorial Hospital Regional Cancer Center
  - Wausau, Wisconsin, United States, 54401
    - Marshfield Clinic - Wausau Center
  - Wausau, Wisconsin, United States, 54401
    - University of Wisconcin Cancer Center at Aspirus Wausau Hospital
  - Wauwatosa, Wisconsin, United States, 53226
    - Oncology Alliance, SC - Milwaukee - West
  - Weston, Wisconsin, United States, 54476
    - Marshfield Clinic - Weston Center
  - Wisconsin Rapids, Wisconsin, United States, 54494
    - Marshfield Clinic - Wisconsin Rapids Center
  - Wisconsin Rapids, Wisconsin, United States, 54494
    - Riverview UW Cancer Center at Riverview Hospital
- Wyoming
  - Sheridan, Wyoming, United States, 82801
    - Welch Cancer Center at Sheridan Memorial Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

Locally Advanced or Metastatic Colorectal Cancer
1. Eligible patients must have histologically or cytologically documented adenocarcinoma of the colon or rectum. Patients must have either locally advanced (unresectable) or metastatic disease. Patients with resected primary tumors who have documented metastases are eligible. Documentation of residual disease by CT scan or surgeon's notes is required for all patients, and histologic confirmation of metastases is strongly encouraged.
2. Patients with a history of colorectal cancer treatment by surgical resection who develop radiological or clinical evidence of metastatic cancer do not require separate histological or cytological confirmation of metastatic disease unless:
  - Either an interval of greater than five years has elapsed between the primary surgery and the development of metastatic disease or
  - The primary cancer was stage I. Clinicians should consider biopsy of lesions to establish the diagnosis of metastatic colorectal cancer in each case if there is substantial clinical ambiguity regarding the nature or source of apparent metastases.
3. At the time of randomization, the intent of this treatment must be indicated palliative or neoadjuvant chemotherapy with the potential for resection of all sites of metastatic disease.
Only patients with a wildtype K-ras gene as determined by the laboratory at the SWOG Solid Tumor Repository or by a local CLIA-certified laboratory are eligible. Patients with a mutation in the K-ras gene are ineligible. All patients must have available for analysis of K-ras status at least one H and E slide and one paraffin block of the previously resected primary colorectal tumor and/or a tumor deposit. For patients registered and randomized based on local CLIA-certified laboratory results, SWOG analysis will be confirmatory only.
Prior Treatment
1. No prior systemic treatment for advanced or metastatic colorectal cancer is allowed. Prior regional chemotherapy (eg, hepatic arterial infusion) is also not allowed.
  - Patients may have received prior adjuvant chemotherapy that included fluorouracil alone or in combination with fluorouracil and oxaliplatin or irinotecan (no more than 6 months); or radiation with radiosensitizing chemotherapy.
  - The last course of adjuvant chemotherapy must have concluded > 12 months prior to colorectal cancer recurrence.
  - Patients may have received neoadjuvant chemo-radiation with capecitabine or 5-fluorouracil.
  - Patients may not have received itraconazole or ketoconazole less than 4 weeks prior to randomization.
  - No prior exposure to any tyrosine kinase inhibitors or other agents (including protein products, monoclonal antibodies, antisense, etc.) that target VEGF or EGF receptors is allowed.
  - No prior treatment with bevacizumab or cetuximab.
2. Patients may not have had prior radiotherapy to greater than 25% of bone marrow.
  (Standard adjuvant rectal cancer chemoradiation will not exclude patient from protocol entry.) Radiation must have concluded ≥ 4 weeks prior to randomization.
3. Patients should have completed any major surgery ≥ 4 weeks from randomization. Patients must have completed any minor surgery ≥ 2 weeks prior to randomization. Patients must have fully recovered from the procedure. (Insertion of a vascular access device is not considered major or minor surgery.)
No previous or concurrent malignancy is allowed except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the patient has been disease-free for five years.
For patients who are to receive FOLFIRI: No evidence of Gilbert's Syndrome or of homozygosity for the UGT1A1*28 allele.
1. Patients with Gilbert's Syndrome may have a greater risk of irinotecan toxicity due to the abnormal glucuronidation of SN-38. Evidence of Gilbert's Syndrome would include a prior finding of an isolated elevation of indirect bilirubin.
2. UGT1A1 genotyping is not required on this study. However, patients known to be homozygous for the UGT1A1*28 allele are not to receive FOLFIRI for this study. Patients with Gilbert's Syndrome or who are found to be homozygous for the UGT1A1 allele who will receive FOLFOX are eligible.
No sensory peripheral neuropathy of ≥ grade 2 at baseline for patients who are to receive FOLFOX.
No known central nervous system metastases or carcinomatous meningitis.
No interstitial pneumonia or extensive and symptomatic interstitial fibrosis of the lung.
No pleural effusion or ascites that causes ≥ grade 2 dyspnea.
No predisposing colonic or small bowel disorders in which the symptoms are uncontrolled as indicated by baseline pattern of > 3 watery or soft stools daily in patients without a colostomy or ileostomy. Patients with a colostomy or ileostomy may entered at investigator discretion.
Patients must not have an uncontrolled seizure disorder, or active neurological disease.
No current congestive heart failure (New York Heart Association Class II, III or IV)
Patients with history of hypertension must be well controlled ( < 160/90) on a regimen of anti-hypertensive therapy.
Patients on full-dose anticoagulation (eg, warfarin) are eligible provided that both of the following criteria are met:
1. The patient has an in-range INR (usually between 2 and 3) on a stable dose of oral anticoagulant or be on a stable dose of low molecular weight heparin.
2. The patient has no active bleeding or pathological condition that carries a high risk of bleeding (eg, tumor involving major vessels or known varices).
Patients receiving anti-platelet agents are eligible. In addition, patients who are on daily prophylactic aspirin or anticoagulation for atrial fibrillation are eligible.
No significant history of bleeding events or GI perforation:
1. Patients with a history of significant bleeding episodes (eg, hemoptysis, upper or lower GI bleeding ) within 6 months of randomization are not eligible unless the source of bleeding has been resected.
2. Patients with a history of GI perforation within 12 months of randomization are not eligible.
No arterial thrombotic events within 6 months before randomization, including transient ischemic attack (TIA), cerebrovascular accident (CVA), unstable angina or angina requiring surgical or medical intervention in the past 6 months, or myocardial infarction (MI). Patients with clinically significantly peripheral artery disease (eg, claudication on less than one block) or any other arterial thrombotic event are also ineligible.
No serious or non-healing wound, ulcer or bone fracture
Patients with known hypersensitivity to Chinese hamster ovary cell products or to recombinant human or murine antibodies are not eligible.
Non-pregnant and not nursing:
1. Women of child bearing potential must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 72 hours prior to randomization.
2. DNA alkylating agents are known to be teratogenic, and the effects of irinotecan, oxaliplatin, 5-FU, bevacizumab, and cetuximab on a developing fetus at the recommended therapeutic doses are unknown.
3. Women of child-bearing potential include any female who has experienced menarche and who has not undergone surgical sterilization (hysterectomy, bilateral tubal ligation or bilateral oophorectomy) or is not postmenopausal.
4. Postmenopausal is defined as amenorrhea ≥ 12 consecutive months or women on hormone replacement therapy (HRT) with documented serum follicle stimulating hormone (FSH) level > 35 mIU/mL.
5. Women of child-bearing potential also include women who are using oral, implanted or injectable contraceptive hormones or mechanical products such as an intrauterine device or barrier methods (diaphragm, condoms, spermicides) to prevent pregnancy or practicing abstinence or where partner is sterile (eg, vasectomy), should be considered to be of child bearing potential.
ECOG Performance Status of 0-1
Age ≥ 18 years
Required Initial Laboratory Values:
1. Granulocytes ≥ 1500 µL
2. Hemoglobin ≥ 9.0 grams/dL (patient may be transfused to meet this criterion)
3. Platelet count ≥ 100,000/µL
4. Creatinine ≤ 1.5 x Upper limits of normal
5. Bilirubin ≤ 1.5 mg/dL
6. Albumin ≥ 2.5 g/dL
7. Urinalysis ≤ 1 + protein*
  - *Patients discovered to have ≥ 2+ proteinuria at baseline must undergo a 24-hour urine collection that must demonstrate < 1 g of protein/24 hour or have a UPC < 1.0 to allow participation in the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: NONE

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Arm A: FOLFOX or FOLFIRI + bevacizumab Patients receive bevacizumab 5 mg/kg IV every two weeks and then receive either FOLFOX or FOLFIRI every two weeks as described in the intervention section. One cycle is defined as 8 weeks of treatment. Treatment continues until disease progression, unacceptable toxicity or surgery with curative intent as planned.	Biological: bevacizumab Given IV Drug: FOLFOX or Patients receive oxaliplatin 85 mg/m^2 IV infused over two hours followed by leucovorin 400 mg/m^2 IV over 2 hours followed by 5-FU 400 mg/m^2 IV bolus, then 2400 mg/m^2 continuous IV infusion over 46-48 hours Other Names: Eloxatin (oxaliplatin), leucovorin (folinic acid) and 5-Fluorouracil (5-FU) Drug: FOLFIRI Patients receive irinotecan 180 mg/m^2 IV infused over 90 minutes followed by leucovorin 400 mg/m^2 IV over 2 hours followed by 5-FU 400 mg/m^2 IV bolus following leucovorin then 2400 mg/m^2 continuous IV infusion over 46-48 hours. Other Names: CPT-11 (irinotecan), leucovorin (folinic acid), and 5-Fluorouracil (5-FU)
EXPERIMENTAL: Arm B: FOLFOX or FOLFIRI + cetuximab Patients receive cetuximab 400mg/m^2 IV over 2 hours on the first day of treatment, then 250 mg/m^2 IV over 1 hour weekly thereafter. Patients also receive either FOLFOX or FOLFIRI every two weeks as described in the intervention section. One cycle is defined as 8 weeks of treatment. Treatment continues until disease progression, unacceptable toxicity or surgery with curative intent as planned.	Biological: cetuximab Given IV Drug: FOLFOX or Patients receive oxaliplatin 85 mg/m^2 IV infused over two hours followed by leucovorin 400 mg/m^2 IV over 2 hours followed by 5-FU 400 mg/m^2 IV bolus, then 2400 mg/m^2 continuous IV infusion over 46-48 hours Other Names: Eloxatin (oxaliplatin), leucovorin (folinic acid) and 5-Fluorouracil (5-FU) Drug: FOLFIRI Patients receive irinotecan 180 mg/m^2 IV infused over 90 minutes followed by leucovorin 400 mg/m^2 IV over 2 hours followed by 5-FU 400 mg/m^2 IV bolus following leucovorin then 2400 mg/m^2 continuous IV infusion over 46-48 hours. Other Names: CPT-11 (irinotecan), leucovorin (folinic acid), and 5-Fluorouracil (5-FU)
EXPERIMENTAL: Arm C: FOLFOX or FOLFIRI + cetuximab + bevacizumab Patients receive cetuximab 400mg/m^2 IV over 2 hours on the first day of treatment, then 250 mg/m^2 IV over 1 hour weekly thereafter. Also, patients receive bevacizumab 5 mg/kg IV every two weeks and then receive either FOLFOX or FOLFIRI every two weeks as described in the intervention section. One cycle is defined as 8 weeks of treatment. Treatment continues until disease progression, unacceptable toxicity or surgery with curative intent as planned.	Biological: bevacizumab Given IV Biological: cetuximab Given IV Drug: FOLFOX or Patients receive oxaliplatin 85 mg/m^2 IV infused over two hours followed by leucovorin 400 mg/m^2 IV over 2 hours followed by 5-FU 400 mg/m^2 IV bolus, then 2400 mg/m^2 continuous IV infusion over 46-48 hours Other Names: Eloxatin (oxaliplatin), leucovorin (folinic acid) and 5-Fluorouracil (5-FU) Drug: FOLFIRI Patients receive irinotecan 180 mg/m^2 IV infused over 90 minutes followed by leucovorin 400 mg/m^2 IV over 2 hours followed by 5-FU 400 mg/m^2 IV bolus following leucovorin then 2400 mg/m^2 continuous IV infusion over 46-48 hours. Other Names: CPT-11 (irinotecan), leucovorin (folinic acid), and 5-Fluorouracil (5-FU)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival Time Frame: Up to 5 years post-treatment	Survival time will be defined as the time from registration to death. Time to event distributions will be estimated using the Kaplan-Meier method. Overall Survival (OS) will be compared between Arm A and Arm B.	Up to 5 years post-treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-free Survival (PFS) Time Frame: Up to 5 years post-treatment	PFS will be measured from study entry until first documented progression or death from any cause. Time to event distributions will be estimated using the Kaplan-Meier method. PFS will be compared between Arm A and Arm B.	Up to 5 years post-treatment
Time to Treatment Failure Time Frame: Up to 5 years post-treatment		Up to 5 years post-treatment
Duration of Tumor Response Time Frame: Up to 5 years post-treatment		Up to 5 years post-treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alliance for Clinical Trials in Oncology

Collaborators

Bristol-Myers Squibb

National Cancer Institute (NCI)

Southwest Oncology Group

Aptuit

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Data Available: Select individual patient-level data from this trial can be requested from the NCTN/NCORP Data Archive.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2005

Primary Completion (ACTUAL)

February 1, 2015

Study Completion (ACTUAL)

January 1, 2018

Study Registration Dates

First Submitted

December 14, 2005

First Submitted That Met QC Criteria

December 14, 2005

First Posted (ESTIMATE)

December 15, 2005

Study Record Updates

Last Update Posted (ACTUAL)

May 7, 2020

Last Update Submitted That Met QC Criteria

April 28, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

CALGB 80405
U10CA037447 (U.S. NIH Grant/Contract)
CDR0000455161 (OTHER: Physician Data Query)
NCI-2009-00434 (REGISTRY: NCI Clinical Trial Reporting Program Office)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Active, not recruiting

TORC1/2 Inhibitor MLN0128 and Bevacizumab in Treating Patients With Recurrent Glioblastoma or Advanced Solid Tumors

Recurrent Fallopian Tube Carcinoma | Recurrent Ovarian Carcinoma | Recurrent Primary Peritoneal Carcinoma | Ovarian Clear Cell Cystadenocarcinoma | Ovarian Endometrioid Adenocarcinoma | Ovarian Serous Cystadenocarcinoma | Endometrial Clear Cell Adenocarcinoma | Endometrial Serous Adenocarcinoma | Recurrent... and other conditions

United States
National Cancer Institute (NCI)
NRG Oncology

Completed

Bevacizumab With or Without Trebananib in Treating Patients With Recurrent Brain Tumors

Glioblastoma | Gliosarcoma | Recurrent Glioblastoma | Oligodendroglioma | Giant Cell Glioblastoma | Recurrent Brain Neoplasm

United States, Canada
M.D. Anderson Cancer Center

Recruiting

Atezolizumab and Bevacizumab Before Surgery for the Treatment of Resectable Liver Cancer

Stage IB Hepatocellular Carcinoma AJCC v8 | Stage II Hepatocellular Carcinoma AJCC v8 | Resectable Hepatocellular Carcinoma | Stage I Hepatocellular Carcinoma AJCC v8 | Stage IA Hepatocellular Carcinoma AJCC v8

United States
Roswell Park Cancer Institute
National Cancer Institute (NCI)

Recruiting

APL-2 and Pembrolizumab Versus APL-2, Pembrolizumab and Bevacizumab Versus Bevacizumab Alone for the Treatment of Recurrent Ovarian, Fallopian Tube, or Primary Peritoneal Cancer and Malignant Effusion

Recurrent Fallopian Tube Carcinoma | Recurrent Ovarian Carcinoma | Recurrent Primary Peritoneal Carcinoma | Ovarian Endometrioid Adenocarcinoma | Ovarian Clear Cell Adenocarcinoma | Fallopian Tube Adenocarcinoma | Fallopian Tube Serous Adenocarcinoma | Ovarian Serous Adenocarcinoma | Fallopian Tube... and other conditions

United States
National Cancer Institute (NCI)

Completed

Atezolizumab and Bevacizumab in Treating Patients With Recurrent, Persistent, or Metastatic Cervical Cancer

Cervical Adenocarcinoma | Cervical Adenosquamous Carcinoma | Cervical Squamous Cell Carcinoma, Not Otherwise Specified | Stage IVA Cervical Cancer AJCC v6 and v7 | Recurrent Cervical Carcinoma | Stage IV Cervical Cancer AJCC v6 and v7 | Stage IVB Cervical Cancer AJCC v6 and v7

United States
Northwestern University
National Cancer Institute (NCI); Ipsen Biopharmaceuticals

Completed

Irinotecan Liposome and Bevacizumab for the Treatment of Platinum Resistant, Recurrent, or Refractory Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

Recurrent Fallopian Tube Carcinoma | Recurrent Ovarian Carcinoma | Recurrent Primary Peritoneal Carcinoma | Platinum-Resistant Fallopian Tube Carcinoma | Platinum-Resistant Primary Peritoneal Carcinoma | Platinum-Resistant Ovarian Carcinoma | Refractory Ovarian Carcinoma | Refractory Fallopian Tube... and other conditions

United States
Roswell Park Cancer Institute
National Cancer Institute (NCI); Merck Sharp & Dohme LLC; Celldex Therapeutics

Recruiting

Pembrolizumab Combined With Bevacizumab With or Without Agonist Anti-CD40 CDX-1140 for the Treatment of Patients With Recurrent Ovarian Cancer

Recurrent Fallopian Tube Carcinoma | Recurrent Ovarian Carcinoma | Recurrent Primary Peritoneal Carcinoma | Recurrent Endometrial Serous Adenocarcinoma | Ovarian Clear Cell Adenocarcinoma | Recurrent Platinum-Resistant Ovarian Carcinoma | Platinum-Sensitive Ovarian Carcinoma | Recurrent Fallopian... and other conditions

United States
National Cancer Institute (NCI)

Active, not recruiting

Ipilimumab With or Without Bevacizumab in Treating Patients With Stage III-IV Melanoma That Cannot Be Removed by Surgery

Stage IV Cutaneous Melanoma AJCC v6 and v7 | Stage IIIC Cutaneous Melanoma AJCC v7 | Unresectable Melanoma

United States
City of Hope Medical Center
National Cancer Institute (NCI)

Active, not recruiting

Brigatinib and Bevacizumab for the Treatment of ALK-Rearranged Locally Advanced, Metastatic, or Recurrent NSCLC

Metastatic Lung Non-Small Cell Carcinoma | Stage IVA Lung Cancer AJCC v8 | Stage IVB Lung Cancer AJCC v8 | Stage III Lung Cancer AJCC v8 | Stage IV Lung Cancer AJCC v8 | Stage IIIA Lung Cancer AJCC v8 | Stage IIIB Lung Cancer AJCC v8 | Stage IIIC Lung Cancer AJCC v8 | Locally Advanced Lung Non-Small... and other conditions

United States
National Cancer Institute (NCI)

Recruiting

Testing Atezolizumab Alone or Atezolizumab Plus Bevacizumab in People With Advanced Alveolar Soft Part Sarcoma

Metastatic Alveolar Soft Part Sarcoma | Unresectable Alveolar Soft Part Sarcoma

United States

Cetuximab and/or Bevacizumab Combined With Combination Chemotherapy in Treating Patients With Metastatic Colorectal Cancer

A Phase III Trial of Irinotecan / 5-FU / Leucovorin or Oxaliplatin / 5-FU/ Leucovorin With Bevacizumab, or Cetuximab (C225), or With the Combination of Bevacizumab and Cetuximab for Patients With Untreated Metastatic Adenocarcinoma of the Colon or Rectum

Study Overview

Status

Conditions

Intervention / Treatment

Detailed Description

Study Type

Enrollment (Actual)

Phase

Contacts and Locations

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Genders Eligible for Study

Description

Study Plan

How is the study designed?

Design Details

Number of Arms

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Secondary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Collaborators and Investigators

Sponsor

Collaborators

Publications and helpful links

General Publications

Helpful Links

Study record dates

Study Major Dates

Study Start

Primary Completion (ACTUAL)

Study Completion (ACTUAL)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (ESTIMATE)

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Clinical Trials on Colorectal Cancer

Clinical Trials on bevacizumab

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Conditions

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