Combination Chemotherapy in Treating Patients With Advanced Colorectal Cancer

A Randomized Phase III Trial of Three Different Regimens of CPT-11 Plus 5-Fluorouracil and Leucovorin Compared to 5-Fluorouracil and Leucovorin in Patients With Advanced Adenocarcinoma of the Colon and Rectum

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known which regimen of combination chemotherapy is most effective in treating advanced colorectal cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of various combination chemotherapy regimens in treating patients who have advanced, recurrent, or metastatic colorectal cancer that cannot be treated with surgery or radiation therapy.

Study Overview

• Status: Completed
• Conditions: Colorectal Cancer
• Intervention / Treatment: Drug: fluorouracil; Drug: leucovorin calcium; Drug: oxaliplatin; Drug: irinotecan

Detailed Description

OBJECTIVES:

• Compare the time to progression in patients with locally advanced, locally recurrent, or metastatic colorectal adenocarcinoma treated with combinations of oxaliplatin, fluorouracil, leucovorin calcium, and irinotecan.
• Compare the quality of life, response rate, time to treatment failure, and overall survival in patients treated with these regimens.
• Compare the toxicity of these regimens in these patients.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to ECOG performance status (0-1 vs 2), prior adjuvant chemotherapy (yes vs no), prior immunotherapy (yes vs no), and age (under 65 vs 65 and over). Patients are randomized to one of three treatment arms.

Only arm II remains open to accrual.

• Arm I (Saltz regimen): Patients receive irinotecan IV over 90 minutes followed by leucovorin calcium IV over 15 minutes and fluorouracil IV once a week for 4 weeks followed by 2 weeks of rest. Courses repeat every 6 weeks. (Arm I closed to accrual as of March 15, 2002.)
• Arm II (FOLFOX4 regimen): Patients receive oxaliplatin IV over 2 hours on day 1 and leucovorin calcium IV over 2 hours plus fluorouracil IV over 22 hours on days 1 and 2. Courses repeat every 2 weeks.
• Arm III (oxaliplatin plus irinotecan): Patients receive oxaliplatin IV over 2 hours and irinotecan IV over 30 minutes on day 1. Courses repeat every 3 weeks. (Arm III closed to accrual as of March 15, 2002.) Treatment continues in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed before treatment, during treatment (arm specific), and after completion of treatment.

Patients are followed every 3 months for 1 year, every 6 months for 2 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 825 patients (275 per arm) have been accrued for this study thus far. Additional patients are being accrued on arm II. (Arms I and III closed to accrual as of March 15, 2002.)

• Study Type: Interventional
• Enrollment (Actual): 1691
• Phase: Phase 3

Contacts and Locations

Study Locations

• Canada
  • North Vancouver, Canada, V7L 2P9
    • Lions Gate Hospital
  • Alberta
    • Edmonton, Alberta, Canada, T6G 1Z2
      • Cross Cancer Institute
  • British Columbia
    • Kelowna, British Columbia, Canada, V1Y 5L3
      • British Columbia Cancer Agency - Centre for the Southern Interior
    • Nanaimo, British Columbia, Canada, V9S 2B7
      • Nanaimo Cancer Clinic
    • Surrey, British Columbia, Canada, V3V 1Z2
      • British Columbia Cancer Agency - Fraser Valley Cancer Centre
    • Vancouver, British Columbia, Canada, V5Z 4E6
      • British Columbia Cancer Agency
    • Victoria, British Columbia, Canada, V8R 6V5
      • British Columbia Cancer Agency - Vancouver Island Cancer Centre
  • Manitoba
    • Winnipeg, Manitoba, Canada, R2H 2A6
      • St. Boniface General Hospital
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3H 1V7
      • Nova Scotia Cancer Centre
  • Ontario
    • Brampton, Ontario, Canada, L6W 2Z8
      • William Osler Health Centre
    • London, Ontario, Canada, N6A 4L6
      • Cancer Care Ontario-London Regional Cancer Centre
    • Mississauga, Ontario, Canada, L5B 1B8
      • Trillium Health Centre
    • Mississauga, Ontario, Canada, L5M 2N1
      • Credit Valley Hospital
    • Newmarket, Ontario, Canada, L3Y 2P9
      • Southlake Regional Health Centre
    • Peterborough, Ontario, Canada, K9H 7B6
      • Peterborough Oncology Clinic
    • Sault Sainte Marie, Ontario, Canada, P6B 1Y5
      • Algoma District Medical Group
    • St. Catharines, Ontario, Canada, L2R 5K3
      • Hotel Dieu Health Sciences Hospital - Niagara
    • Sudbury, Ontario, Canada, P3E 5J1
      • Northeastern Ontario Regional Cancer Centre, Sudbury
    • Thunder Bay, Ontario, Canada, P7A 7T1
      • Northwestern Ontario Regional Cancer Centre, Thunder Bay
    • Toronto, Ontario, Canada, M5G 1X5
      • Mount Sinai Hospital - Toronto
    • Toronto, Ontario, Canada, M6R 1B5
      • Saint Joseph's Health Centre - Toronto
    • Weston, Ontario, Canada, M9N 1N8
      • Humber River Regional Hospital
  • Prince Edward Island
    • Charlottetown, Prince Edward Island, Canada, C1A 8T5
      • Queen Elizabeth Hospital, PEI
  • Quebec
    • Greenfield Park, Quebec, Canada, J4V 2H1
      • Hopital Charles LeMoyne
    • Montreal, Quebec, Canada, H1T 2M4
      • Maisonneuve-Rosemont Hospital
    • Montreal, Quebec, Canada, H2L-4M1
      • Centre Hospitalier de l'Universite de Montreal
    • Montreal, Quebec, Canada, H2X 3J4
      • CHUM Hopital Saint-Luc
    • Ste-Foy, Quebec, Canada, G1V 4G5
      • L'Hopital Laval
  • Saskatchewan
    • Regina, Saskatchewan, Canada, S4T 7T1
      • Allan Blair Cancer Centre
    • Regina, Saskatchewan, Canada, S4T 7T1
      • Pasqua Hospital
    • Saskatoon, Saskatchewan, Canada, S7N 4H4
      • Saskatoon Cancer Centre
• Puerto Rico
  • Hato Rey, Puerto Rico, 00919-1811
    • Centro Mamografia Hospital Oncologico
  • San Juan, Puerto Rico, 00936-7344
    • San Juan City Hospital
  • San Juan, Puerto Rico, 00927-5800
    • Veterans Affairs Medical Center - San Juan
• South Africa
  • Johannesburg, South Africa, 2193
    • Medical Oncology Centre of Rosebank
  • Pretoria, South Africa, 0001
    • Pretoria Academic Hospitals
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233-1996
      • Veterans Affairs Medical Center - Birmingham
    • Mobile, Alabama, United States, 36688
      • MBCCOP - Gulf Coast
  • Arizona
    • Phoenix, Arizona, United States, 85006-2726
      • CCOP - Greater Phoenix
    • Phoenix, Arizona, United States, 85012
      • Veterans Affairs Medical Center - Phoenix (Hayden)
    • Phoenix, Arizona, United States, 85054-4502
      • Mayo Clinic Hospital
    • Scottsdale, Arizona, United States, 85259
      • Mayo Clinic Scottsdale
    • Tucson, Arizona, United States, 85724
      • Arizona Cancer Center
    • Tucson, Arizona, United States, 85723
      • Veterans Affairs Medical Center - Tucson
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • University of Arkansas for Medical Sciences
    • Little Rock, Arkansas, United States, 72205
      • Veterans Affairs Medical Center - Little Rock (McClellan)
  • California
    • Duarte, California, United States, 91010-3000
      • Cancer Center and Beckman Research Institute, City of Hope
    • La Jolla, California, United States, 92093-0658
      • University of California San Diego Cancer Center
    • Long Beach, California, United States, 90822
      • Veterans Affairs Medical Center - Long Beach
    • Los Angeles, California, United States, 90095-1781
      • Jonsson Comprehensive Cancer Center, UCLA
    • Los Angeles, California, United States, 90033-0804
      • USC/Norris Comprehensive Cancer Center and Hospital
    • Los Angeles, California, United States, 90073
      • Veterans Affairs Medical Center - West Los Angeles
    • Martinez, California, United States, 94553
      • Veterans Affairs Outpatient Clinic - Martinez
    • Monterey, California, United States, 93940
      • Community Hospital of the Monterey Peninsula
    • Oakland, California, United States, 94609-3305
      • CCOP - Bay Area Tumor Institute
    • Orange, California, United States, 92868
      • Chao Family Comprehensive Cancer Center
    • Palo Alto, California, United States, 94304
      • Veterans Affairs Medical Center - Palo Alto
    • Sacramento, California, United States, 95817
      • University of California Davis Medical Center
    • San Francisco, California, United States, 94121
      • Veterans Affairs Medical Center - San Francisco
    • San Francisco, California, United States, 94143-0128
      • UCSF Cancer Center and Cancer Research Institute
    • Santa Rosa, California, United States, 95403
      • CCOP - Santa Rosa Memorial Hospital
    • Stanford, California, United States, 94305-5408
      • Stanford University Medical Center
    • Travis Air Force Base, California, United States, 94535
      • David Grant Medical Center
  • Colorado
    • Aurora, Colorado, United States, 80011
      • Columbia Medical Center of Aurora North Campus
    • Colorado Springs, Colorado, United States, 80933
      • Penrose Cancer Center
    • Denver, Colorado, United States, 80210
      • Porter Adventist Hospital
    • Denver, Colorado, United States, 80220
      • Veterans Affairs Medical Center - Denver
    • Denver, Colorado, United States, 80218
      • Presbyterian-St Luke's Medical Center
    • Denver, Colorado, United States, 80010
      • University of Colorado Cancer Center
    • Denver, Colorado, United States, 80218
      • St. Joseph Hospital
    • Denver, Colorado, United States, 80209-5031
      • CCOP - Colorado Cancer Research Program, Inc.
    • Denver, Colorado, United States, 80220
      • HealthOne Rose Medical Center
    • Englewood, Colorado, United States, 80110
      • Swedish Medical Center
    • Fort Collins, Colorado, United States, 80524
      • Poudre Valley Hospital
    • Fort Collins, Colorado, United States, 80528
      • Poudre Valley Radiation Oncology
    • Fort Collins, Colorado, United States, 80524-4038
      • Rocky Mountain Cancer Centers - Northern Colorado
    • Pueblo, Colorado, United States, 81004
      • St. Mary-Corwin Regional Medical Center
  • Connecticut
    • Bristol, Connecticut, United States, 06011-0977
      • Bristol Hospital
    • Farmington, Connecticut, United States, 06360-7106
      • University of Connecticut Health Center
    • Hartford, Connecticut, United States, 06105
      • St. Francis Hospital and Medical Center
    • New Britain, Connecticut, United States, 06050
      • New Britain General Hospital
    • New London, Connecticut, United States, 06320
      • Lawrence and Memorial Hospital
    • Norwich, Connecticut, United States, 06360
      • William W. Backus Hospital
    • Torrington, Connecticut, United States, 06790
      • Northwestern Connecticut Oncology-Hematology Associates
  • Delaware
    • Wilmington, Delaware, United States, 19899
      • CCOP - Christiana Care Health Services
  • District of Columbia
    • Washington, District of Columbia, United States, 20307-5000
      • Walter Reed Army Medical Center
  • Florida
    • Gainesville, Florida, United States, 32610-0277
      • University of Florida - Gainesville
    • Jacksonville, Florida, United States, 32224
      • Mayo Clinic
    • Jacksonville, Florida, United States, 32209
      • University of Florida Health Science Center - Jacksonville
    • Jacksonville, Florida, United States, 32207
      • Baptist Regional Cancer Institute - Jacksonville
    • Miami Beach, Florida, United States, 33140
      • CCOP - Mount Sinai Medical Center
    • Tampa, Florida, United States, 33612-9497
      • H. Lee Moffitt Cancer Center and Research Institute
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Emory University Hospital - Atlanta
    • Atlanta, Georgia, United States, 30342-1701
      • CCOP - Atlanta Regional
    • Atlanta, Georgia, United States, 30335
      • Grady Memorial Hospital
    • Decatur, Georgia, United States, 30033
      • Veterans Affairs Medical Center - Atlanta (Decatur)
    • Fort Gordon, Georgia, United States, 30905-5650
      • Dwight David Eisenhower Army Medical Center
  • Hawaii
    • Honolulu, Hawaii, United States, 96813
      • Cancer Research Center of Hawaii
  • Illinois
    • Bloomington, Illinois, United States, 61701-3081
      • Bromenn Lifecare Center
    • Bloomington, Illinois, United States, 61701
      • St. Joseph's Hospital Medical Center
    • Canton, Illinois, United States, 61520
      • Graham Hospital Association
    • Carthage, Illinois, United States, 62321
      • Memorial Hospital
    • Chicago, Illinois, United States, 60612
      • Veterans Affairs Medical Center - Chicago (Westside Hospital)
    • Chicago, Illinois, United States, 60637-1470
      • University of Chicago Cancer Research Center
    • Chicago, Illinois, United States, 60611-3013
      • Robert H. Lurie Comprehensive Cancer Center, Northwestern University
    • Chicago, Illinois, United States, 60611
      • Veterans Affairs Medical Center - Lakeside Chicago
    • Chicago, Illinois, United States, 60616
      • Mercy Hospital and Medical Center
    • Chicago, Illinois, United States, 60611-2998
      • Hematology-Oncology Associates of Illinois
    • Chicago, Illinois, United States, 60611
      • Hematology Oncology Associates of Illinois - Lake Shore Dr
    • Decatur, Illinois, United States, 62526
      • CCOP - Central Illinois
    • Des Plaines, Illinois, United States, 60016
      • Holy Family Medical Center
    • Effingham, Illinois, United States, 62401
      • St. Anthony's Memorial Hospital
    • Elk Grove Village, Illinois, United States, 60007
      • Northwest Oncology and Hematology, S.C.
    • Eureka, Illinois, United States, 61530
      • Eureka Hospital
    • Evanston, Illinois, United States, 60201
      • CCOP - Evanston
    • Galesburg, Illinois, United States, 61401
      • Galesburg Clinic
    • Galesburg, Illinois, United States, 61401
      • InterCommunity Cancer Center of Western Illinois
    • Galesburg, Illinois, United States, 61402
      • Galesburg Cottage Hospital
    • Glenview, Illinois, United States, 60025
      • Glenbrook Hospital
    • Harvey, Illinois, United States, 60426
      • Ingalls Memorial Hospital
    • Havana, Illinois, United States, 62644
      • Mason District Hospital
    • Highland Park, Illinois, United States, 60035
      • Hematology Oncology Associates of Illinois-Highland Park
    • Hines, Illinois, United States, 60141
      • Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital)
    • Hinsdale, Illinois, United States, 60521
      • Hinsdale Hematology Oncology Associates
    • Hopedale, Illinois, United States, 61747
      • Hopedale Medical Complex Hospital
    • Joliet, Illinois, United States, 60432
      • Silver Cross Hospital
    • Joliet, Illinois, United States, 60435
      • Joliet Oncology/Hematology Associates, Ltd.
    • Joliet, Illinois, United States, 60435
      • Saint Joseph Medical Center
    • Kewanee, Illinois, United States, 61443
      • Kewanee Hospital
    • Lake Forest, Illinois, United States, 60045
      • Deerpath Medical Associates
    • Libertyville, Illinois, United States, 60048
      • North Shore Oncology Hematology Associates
    • Macomb, Illinois, United States, 61455
      • Mcdonough District Hospital
    • Maywood, Illinois, United States, 60153
      • Loyola University Medical Center
    • Melrose Park, Illinois, United States, 60160
      • Hematology/Oncology Associates of Illinois, LLC
    • Mendota, Illinois, United States, 61342
      • Mendota Community Hospital
    • Moline, Illinois, United States, 61265-1291
      • Trinity Medical Center
    • Morris, Illinois, United States, 60450
      • Morris Hospital
    • Normal, Illinois, United States, 61761
      • Bromenn Regional Medical Center
    • Normal, Illinois, United States, 61761
      • Community Cancer Center
    • Oak Park, Illinois, United States, 60304
      • Hematology Oncology Associates of Illinois, LLC
    • Ottawa, Illinois, United States, 61350
      • Community Hospital of Ottawa
    • Pekin, Illinois, United States, 61554
      • Pekin Hospital
    • Peoria, Illinois, United States, 61636
      • Methodist Medical Center of Illinois
    • Peoria, Illinois, United States, 61614
      • Proctor Hospital
    • Peoria, Illinois, United States, 61602
      • Oncology/Hematology Associates of Central Illinois, P.C.
    • Peoria, Illinois, United States, 61637
      • St. Francis Medical Center
    • Peoria, Illinois, United States, 61614
      • Peoria Urological Associates
    • Peoria, Illinois, United States, 61602
      • Illinois Oncology Research Association
    • Peoria, Illinois, United States, 61603
      • Affiliated Urology Specialists
    • Peoria, Illinois, United States, 61603
      • Midwest Urological Group
    • Peoria, Illinois, United States, 61636
      • Midwest Radiation Oncology Physicians
    • Peru, Illinois, United States, 61354
      • Illinois Valley Community Hospital
    • Pontiac, Illinois, United States, 61764
      • St. James Hospital
    • Princeton, Illinois, United States, 61356
      • Perry Memorial Hospital
    • Rock Island, Illinois, United States, 61201
      • Trinity Medical Center
    • Rockford, Illinois, United States, 61104-2315
      • Swedish-American Health System
    • Rushville, Illinois, United States, 62681
      • Sarah D. Culbertson Memorial Hospital
    • Skokie, Illinois, United States, 60076
      • Hematology Oncology Associates - Skokie
    • Skokie, Illinois, United States, 60076
      • Edward H. Kaplan MD and Associates
    • Skokie, Illinois, United States, 60077
      • Midwest Cancer Research Group, Inc.
    • Spring Valley, Illinois, United States, 61362
      • St. Margaret's Hospital
    • Spring Valley, Illinois, United States, 61362
      • Valley Cancer Center
    • Urbana, Illinois, United States, 61801
      • Carle Cancer Center
    • Urbana, Illinois, United States, 61801
      • Carle Foundation Hospital
  • Indiana
    • Evansville, Indiana, United States, 47715
      • Therapy Associates Hematology/Oncology
    • Lafayette, Indiana, United States, 47904
      • Oncology Institute of Greater Lafayette
  • Iowa
    • Ames, Iowa, United States, 50010
      • McFarland Clinic, P.C.
    • Ames, Iowa, United States, 50010
      • William R. Bliss Cancer Center
    • Bettendorf, Iowa, United States, 52722
      • Hematology Oncology Associates of the Quad Cities
    • Carroll, Iowa, United States, 51401
      • Saint Anthony Regional Hospital
    • Cedar Rapids, Iowa, United States, 52403
      • Cedar Rapids Oncology Associates
    • Cedar Rapids, Iowa, United States, 52403
      • Mercy Medical Center
    • Cedar Rapids, Iowa, United States, 52406
      • St. Luke's Hospital
    • Council Bluffs, Iowa, United States, 51503
      • Alegent Health Southwest Iowa Medical Center
    • Des Moines, Iowa, United States, 50309
      • Iowa Methodist Medical Center
    • Des Moines, Iowa, United States, 50314
      • Medical Oncology and Hematology Associates
    • Des Moines, Iowa, United States, 50314
      • Mercy Hospital Medical Center
    • Des Moines, Iowa, United States, 50309
      • Medical Oncology and Hematology Associates
    • Des Moines, Iowa, United States, 50309
      • Des Moines General Hospital
    • Des Moines, Iowa, United States, 50316-2392
      • Iowa Lutheran Hospital
    • Iowa City, Iowa, United States, 52242-1009
      • Holden Comprehensive Cancer Center at the University of Iowa
    • Mason City, Iowa, United States, 50401
      • Mercy Cancer Center
    • Missouri Valley, Iowa, United States, 51555-1199
      • Community Memorial Hospital
    • Onawa, Iowa, United States, 51040
      • Burgess Health Center
    • Ottumwa, Iowa, United States, 52501
      • Ottumwa Regional Health Center
    • Ottumwa, Iowa, United States, 52501
      • Oncology & Hematology of Ottumwa, PC
    • Sioux City, Iowa, United States, 51101-1733
      • Siouxland Hematology-Oncology
    • Sioux City, Iowa, United States, 51104
      • St. Luke's Regional Medical Center
    • Sioux City, Iowa, United States, 51101
      • Mercy Medical Center - Sioux City
  • Kansas
    • Arkansas City, Kansas, United States, 67005
      • Cancer Center of Kansas - Arkansas City
    • Chanute, Kansas, United States, 66720
      • Cancer Center of Kansas - Chanute
    • Dodge City, Kansas, United States, 67801
      • Cancer Center of Kansas - Dodge City
    • Dodge City, Kansas, United States, 67801
      • Radiation Oncology Center
    • Halstead, Kansas, United States, 67056
      • Halstead Cancer Center of Kansas
    • Kansas City, Kansas, United States, 66160-7357
      • University of Kansas Medical Center
    • Kingman, Kansas, United States, 67068
      • Cancer Center of Kansas - Kingman
    • Liberal, Kansas, United States, 67901
      • Liberal Cancer Center of Kansas
    • Newton, Kansas, United States, 67114
      • Cancer Center of Kansas - Newton
    • Pratt, Kansas, United States, 67124
      • Pratt Cancer Center of Kansas
    • Salina, Kansas, United States, 67401
      • Cancer Center of Kansas - Salina
    • Wellington, Kansas, United States, 67152
      • Cancer Center of Kansas - Wellington
    • Wichita, Kansas, United States, 67214
      • Cancer Center of Kansas - Wichita
    • Wichita, Kansas, United States, 67214-3882
      • CCOP - Wichita
    • Wichita, Kansas, United States, 67218
      • Veterans Affairs Medical Center - Wichita
    • Wichita, Kansas, United States, 67214
      • Via Christi Regional Medical Center
    • Wichita, Kansas, United States, 67208
      • Associates in Women's Health - Wichita
    • Wichita, Kansas, United States, 67208
      • Wichita Clinic Cancer Medicine Associates, P.A.
    • Winfield, Kansas, United States, 67156
      • Cancer Center of Kansas - Winfield
  • Kentucky
    • Lexington, Kentucky, United States, 40511-1093
      • Veterans Affairs Medical Center - Lexington
    • Lexington, Kentucky, United States, 40536-0084
      • Albert B. Chandler Medical Center, University of Kentucky
  • Louisiana
    • New Orleans, Louisiana, United States, 70112
      • Tulane University School of Medicine
    • New Orleans, Louisiana, United States, 70112
      • MBCCOP - LSU Health Sciences Center
    • Shreveport, Louisiana, United States, 71130-3932
      • Louisiana State University Health Sciences Center - Shreveport
    • Shreveport, Louisiana, United States, 71130
      • Veterans Affairs Medical Center - Shreveport
  • Maine
    • Togus, Maine, United States, 04330
      • Veterans Affairs Medical Center - Togus
  • Maryland
    • Annapolis, Maryland, United States, 21401
      • Anne Arundel Medical Center
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Dana-Farber Cancer Institute
    • Boston, Massachusetts, United States, 02118
      • Boston Medical Center
    • Boston, Massachusetts, United States, 02111
      • New England Medical Center Hospital
    • Jamaica Plain, Massachusetts, United States, 02130
      • Veterans Affairs Medical Center - Boston (Jamaica Plain)
    • Jamaica Plain, Massachusetts, United States, 02130
      • Faulkner Hospital
    • Medford, Massachusetts, United States, 02155
      • Lawrence Memorial Hospital of Medford/Hallmark Health Systems
    • Taunton, Massachusetts, United States, 02780
      • Morton Hospital & Medical Center
    • Worcester, Massachusetts, United States, 01655
      • University of Massachusetts Memorial Medical Center
  • Michigan
    • Adrian, Michigan, United States, 49221
      • Bixby Medical Center
    • Ann Arbor, Michigan, United States, 48109-0752
      • University of Michigan Comprehensive Cancer Center
    • Ann Arbor, Michigan, United States, 48105
      • Veterans Affairs Medical Center - Ann Arbor
    • Ann Arbor, Michigan, United States, 48106
      • Saint Joseph Mercy Hospital
    • Detroit, Michigan, United States, 48202
      • Henry Ford Hospital
    • Detroit, Michigan, United States, 48201-1379
      • Barbara Ann Karmanos Cancer Institute
    • Detroit, Michigan, United States, 48201-1932
      • Veterans Affairs Medical Center - Detroit
    • Detroit, Michigan, United States, 48236
      • St. John Hospital and Medical Center
    • Flint, Michigan, United States, 48503
      • Genesee Regional Medical Center
    • Grand Rapids, Michigan, United States, 49503
      • CCOP - Grand Rapids Clinical Oncology Program
    • Kalamazoo, Michigan, United States, 49007
      • West Michigan Cancer Center
    • Kalamazoo, Michigan, United States, 49007
      • Bronson Methodist Hospital
    • Kalamazoo, Michigan, United States, 49048-1666
      • Borgess Medical Center
    • Lansing, Michigan, United States, 48909
      • Sparrow Regional Cancer Center
    • Madison Heights, Michigan, United States, 48071-3457
      • Office of E. Michael Lodish
    • Monroe, Michigan, United States, 48162
      • Community Cancer Center of Monroe
    • Saginaw, Michigan, United States, 48601
      • St. Mary's Medical Center
    • Saginaw, Michigan, United States, 48602
      • Balcueva Clinic
    • Southfield, Michigan, United States, 48075-9975
      • Providence Hospital - Southfield
    • Warren, Michigan, United States, 48093-3494
      • St. John Macomb Hospital
  • Minnesota
    • Alexandria, Minnesota, United States, 56308
      • Alexandria Clinic
    • Alexandria, Minnesota, United States, 56308
      • Alexandria Radiation Oncology
    • Brainerd, Minnesota, United States, 56401
      • Brainerd Medical Center
    • 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 Hospital
    • Duluth, Minnesota, United States, 55805
      • Miller-Dwan Medical Center
    • Duluth, Minnesota, United States, 55805
      • St. Mary's/Duluth Clinic Health System
    • Duluth, Minnesota, United States, 55805
      • Duluth Clinic
    • Edina, Minnesota, United States, 55435
      • Fairview-Southdale Hospital
    • Fergus Falls, Minnesota, United States, 56537
      • Fergus Falls Medical Group
    • Fridley, Minnesota, United States, 55432
      • Mercy/Unity Hospitals
    • Hibbing, Minnesota, United States, 55746
      • Central Mesabi Medical Center
    • Hibbing, Minnesota, United States, 55746
      • Duluth Clinic - Hibbing
    • Hibbing, Minnesota, United States, 55746
      • Radiation Therapy Center
    • Hutchinson, Minnesota, United States, 55350
      • Hutchinson Area Health Care
    • Litchfield, Minnesota, United States, 55355
      • Meeker County Memorial Hospital
    • Maplewood, Minnesota, United States, 55109
      • St. John's Hospital
    • Minneapolis, Minnesota, United States, 55417
      • Veterans Affairs Medical Center - Minneapolis
    • Minneapolis, Minnesota, United States, 55455
      • University of Minnesota Cancer Center
    • Minneapolis, Minnesota, United States, 55407
      • Abbott-Northwestern Hospital
    • Minneapolis, Minnesota, United States, 55407
      • Virginia Piper Cancer Institute
    • Minneapolis, Minnesota, United States, 55415
      • Hennepin County Medical Center - Minneapolis
    • Minneapolis, Minnesota, United States, 55442-2900
      • North Memorial Research Center
    • Minneapolis, Minnesota, United States, 55454-1395
      • Fairview University Medical Center - Riverside Campus
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic Cancer Center
    • Saint Cloud, Minnesota, United States, 56303
      • St. Cloud Hospital
    • Saint Cloud, Minnesota, United States, 56303
      • CentraCare Health Plaza
    • Saint Louis Park, Minnesota, United States, 55416
      • CCOP - Metro-Minnesota
    • Saint Louis Park, Minnesota, United States, 55416
      • Park Nicollet Clinic
    • Saint Paul, Minnesota, United States, 55101
      • Regions Hospital
    • Saint Paul, Minnesota, United States, 55102
      • United Hospital
    • Saint Paul, Minnesota, United States, 55102
      • Healtheast Cancer Care
    • Shakopee, Minnesota, United States, 55379
      • Saint Francis Regional Medical Center
    • Waconia, Minnesota, United States, 55387
      • Ridgeview Medical Center
    • Willmar, Minnesota, United States, 56201
      • Rice Memorial Hospital
  • Mississippi
    • Biloxi, Mississippi, United States, 39531-2410
      • Veterans Affairs Medical Center - Biloxi
    • Jackson, Mississippi, United States, 39216-4505
      • University of Mississippi Medical Center
    • Jackson, Mississippi, United States, 39216
      • Veterans Affairs Medical Center - Jackson
    • Keesler Air Force Base, Mississippi, United States, 39534-2576
      • Keesler Medical Center - Keesler AFB
  • Missouri
    • Columbia, Missouri, United States, 65201
      • Veterans Affairs Medical Center - Columbia (Truman Memorial)
    • Columbia, Missouri, United States, 65203
      • Ellis Fischel Cancer Center - Columbia
    • Kansas City, Missouri, United States, 64128
      • Veterans Affairs Medical Center - Kansas City
    • Kansas City, Missouri, United States, 64131
      • CCOP - Kansas City
    • Saint Louis, Missouri, United States, 63110
      • Barnes-Jewish Hospital
    • Saint Louis, Missouri, United States, 63110-0250
      • St. Louis University Health Sciences Center
    • Saint Louis, Missouri, United States, 63141
      • CCOP - St. Louis-Cape Girardeau
    • Springfield, Missouri, United States, 65807
      • CCOP - Cancer Research for the Ozarks
  • Montana
    • Billings, Montana, United States, 59101
      • CCOP - Montana Cancer Consortium
  • Nebraska
    • Fremont, Nebraska, United States, 68025-2387
      • Fremont Area Medical Center
    • Lincoln, Nebraska, United States, 68506
      • Bryan LGH Medical Center East
    • Lincoln, Nebraska, United States, 68510
      • St. Elizabeth Regional Medical Center
    • Lincoln, Nebraska, United States, 68502-3780
      • Bryan LGH Medical Center
    • Lincoln, Nebraska, United States, 68506-5247
      • Prairie View Clinic
    • Lincoln, Nebraska, United States, 68506
      • Office of Susan Hansen, M.D.
    • Lincoln, Nebraska, United States, 68510
      • Wedgewood Medical Center
    • Lincoln, Nebraska, United States, 68516
      • Southeast Nebraska Hematology
    • Lincoln, Nebraska, United States, 68516
      • Southeast Nebreska Hematology-Oncology Consultants, PC
    • Lincoln, Nebraska, United States, 68516
      • Williamsburg Radiation Oncology Center
    • Omaha, Nebraska, United States, 68198-3330
      • University of Nebraska Medical Center
    • Omaha, Nebraska, United States, 68105
      • Veterans Affairs Medical Center - Omaha
    • Omaha, Nebraska, United States, 68124
      • Bergan Mercy Medical Center
    • Omaha, Nebraska, United States, 68122
      • Alegent Health - Immanuel Medical Center
    • Omaha, Nebraska, United States, 68114
      • Oncology Hematology West, P.C.
    • Omaha, Nebraska, United States, 68131-2197
      • Creighton University Cancer Center
    • Omaha, Nebraska, United States, 68131-2197
      • St. Joseph Hospital
    • Papillion, Nebraska, United States, 68046-4194
      • Alegent Health-Midlands Community Hospital
  • Nevada
    • Las Vegas, Nevada, United States, 89106
      • CCOP - Southern Nevada Cancer Research Foundation
  • New Hampshire
    • Lebanon, New Hampshire, United States, 03756-0002
      • Norris Cotton Cancer Center
  • New Jersey
    • Cherry Hill, New Jersey, United States, 08046
      • Center for Cancer and Hematologic Disease
    • Elizabeth, New Jersey, United States, 07201
      • Trinitas Hospital - Jersey Street Campus
    • Flemington, New Jersey, United States, 08822
      • Hunterdon Regional Cancer Center
    • Millville, New Jersey, United States, 08332
      • South Jersey Regional Cancer Center
    • Mount Holly, New Jersey, United States, 08060
      • Fox Chase Cancer Center at Virtua Memorial Hospital Burlington County
    • New Brunswick, New Jersey, United States, 08903
      • Cancer Institute of New Jersey
    • Red Bank, New Jersey, United States, 07701
      • Riverview Medical Center - Booker Cancer Center
    • Trenton, New Jersey, United States, 08629
      • St. Francis Medical Center
    • Vineland, New Jersey, United States, 08360
      • Southern Oncology-Hematology Associates, P.A.
    • Voorhees, New Jersey, United States, 08043
      • Comprehensive Cancer and Hematology Associates
    • Willingboro, New Jersey, United States, 08046
      • Burlington County Hematology Oncology Association, P.A.
  • New Mexico
    • Albuquerque, New Mexico, United States, 87108-5138
      • Veterans Affairs Medical Center - Albuquerque
    • Albuquerque, New Mexico, United States, 87131
      • MBCCOP - University of New Mexico HSC
  • New York
    • Bronx, New York, United States, 10461
      • Albert Einstein Comprehensive Cancer Center
    • Buffalo, New York, United States, 14215
      • Veterans Affairs Medical Center - Buffalo
    • Cooperstown, New York, United States, 13326
      • Mary Imogene Bassett Hospital
    • Manhasset, New York, United States, 11030
      • CCOP - North Shore University Hospital
    • Manhasset, New York, United States, 11030
      • Schneider Children's Hospital at North Shore
    • New York, New York, United States, 10021
      • Memorial Sloan-Kettering Cancer Center
    • New York, New York, United States, 10016
      • NYU School of Medicine's Kaplan Comprehensive Cancer Center
    • New York, New York, United States, 10021
      • New York Presbyterian Hospital - Cornell Campus
    • New York, New York, United States, 10029
      • Mount Sinai Medical Center, NY
    • New York, New York, United States, 10032
      • Herbert Irving Comprehensive Cancer Center
    • New York, New York, United States, 10010
      • Veterans Affairs Medical Center - New York
    • Rochester, New York, United States, 14621
      • Rochester General Hospital
    • Syracuse, New York, United States, 13210
      • State University of New York - Upstate Medical University
    • Syracuse, New York, United States, 13210
      • Veterans Affairs Medical Center - Syracuse
    • Syracuse, New York, United States, 13217
      • CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599-7295
      • Lineberger Comprehensive Cancer Center, UNC
    • Durham, North Carolina, United States, 27705
      • Veterans Affairs Medical Center - Durham
    • Durham, North Carolina, United States, 27710
      • Duke Comprehensive Cancer Center
    • Winston-Salem, North Carolina, United States, 27104-4241
      • CCOP - Southeast Cancer Control Consortium
    • Winston-Salem, North Carolina, United States, 27157-1082
      • Comprehensive Cancer Center at Wake Forest University
  • North Dakota
    • Bismarck, North Dakota, United States, 58501
      • Medcenter One Health System
    • Bismarck, North Dakota, United States, 58501
      • Mid Dakota Clinic, P.C.
    • Bismarck, North Dakota, United States, 58502
      • St. Alexius Medical Center
    • Bismarck, North Dakota, United States, 58501-4445
      • Bismarck Cancer Center
    • Fargo, North Dakota, United States, 58122
      • Meritcare Roger Maris Cancer Center
    • Fargo, North Dakota, United States, 58122
      • CCOP - Merit Care Hospital
    • Grand Forks, North Dakota, United States, 58201
      • Altru Health Systems
    • Grand Forks, North Dakota, United States, 58206
      • Altru Cancer Center
  • Ohio
    • Akron, Ohio, United States, 44309
      • Akron City Hospital
    • Bowling Green, Ohio, United States, 43402
      • Wood County Oncology Center
    • Canton, Ohio, United States, 44710
      • Aultman Cancer Center
    • Canton, Ohio, United States, 44708
      • Mercy Ireland Cancer Center
    • Cincinnati, Ohio, United States, 45220-2288
      • Veterans Affairs Medical Center - Cincinnati
    • Cincinnati, Ohio, United States, 45267-0502
      • Barrett Cancer Center, The University Hospital
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic Taussig Cancer Center
    • Cleveland, Ohio, United States, 44106-5065
      • Ireland Cancer Center
    • Columbus, Ohio, United States, 43210-1240
      • Arthur G. James Cancer Hospital - Ohio State University
    • Columbus, Ohio, United States, 43206
      • CCOP - Columbus
    • Dayton, Ohio, United States, 45428
      • Veterans Affairs Medical Center - Dayton
    • Findlay, Ohio, United States, 45840
      • Woman Wise Blanchard Valley Regional Health Center
    • Fremont, Ohio, United States, 43420
      • Fremont Memorial Hospital
    • Kenton, Ohio, United States, 43326
      • Office of Sharon Cole, M.D.
    • Kettering, Ohio, United States, 45429
      • CCOP - Dayton
    • Lima, Ohio, United States, 45804
      • Lima Memorial Hospital
    • Lima, Ohio, United States, 45801
      • St. Rita's Medical Center
    • Maumee, Ohio, United States, 43537
      • Saint Luke's Hospital
    • Maumee, Ohio, United States, 43537
      • North West Ohio Oncology Center
    • Oregon, Ohio, United States, 43616
      • St. Charles Hospital
    • Sandusky, Ohio, United States, 44870
      • Firelands Regional Medical Center
    • Sandusky, Ohio, United States, 44870
      • North Coast Cancer Care, Inc.
    • Sylvania, Ohio, United States, 43560
      • Flower Hospital - Pro Medica Health System
    • Toledo, Ohio, United States, 43608
      • St. Vincent Mercy Medical Center
    • Toledo, Ohio, United States, 43606
      • Toledo Hospital
    • Toledo, Ohio, United States, 43623
      • Toledo Clinic, Inc.
    • Toledo, Ohio, United States, 43604
      • Riverside Hospital
    • Toledo, Ohio, United States, 43614-0008
      • Medical College of Ohio Hospital
    • Toledo, Ohio, United States, 43614
      • MCO Cancer Institute
    • Toledo, Ohio, United States, 43623-4474
      • Haematology-Oncology Associates, Inc.
    • Wauseon, Ohio, United States, 43567
      • Fulton County Health Center
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104
      • Oklahoma Medical Research Foundation
    • Oklahoma City, Oklahoma, United States, 73104
      • Veterans Affairs Medical Center - Oklahoma City
    • Tulsa, Oklahoma, United States, 74136
      • CCOP - Oklahoma
  • Oregon
    • Portland, Oregon, United States, 97207
      • Veterans Affairs Medical Center - Portland
    • Portland, Oregon, United States, 97213
      • CCOP - Columbia River Program
    • Portland, Oregon, United States, 97201-3098
      • Oregon Cancer Center
  • Pennsylvania
    • Allentown, Pennsylvania, United States, 18103
      • Lehigh Valley Hospital
    • Bethlehem, Pennsylvania, United States, 18017
      • Muhlenberg Hospital Center
    • Carbondale, Pennsylvania, United States, 18407
      • Marion Community Hospital
    • Danville, Pennsylvania, United States, 17822-2001
      • Geisinger Medical Center
    • Drexel Hill, Pennsylvania, United States, 19026
      • Delaware County Memorial Hospital
    • DuBois, Pennsylvania, United States, 15801-0447
      • DuBois Regional Medical Center
    • Greenville, Pennsylvania, United States, 16125
      • UPMC Horizon
    • Harrisburg, Pennsylvania, United States, 17105-8700
      • Pinnacle Health Hospitals
    • Honesdale, Pennsylvania, United States, 18431-1498
      • Wayne Memorial Hospital
    • Johnstown, Pennsylvania, United States, 15901
      • UPCI @ UPMC Lee Hospital
    • Johnstown, Pennsylvania, United States, 15905
      • Conemaugh Memorial Hospital
    • Kittanning, Pennsylvania, United States, 16201-8808
      • Armstrong County Memorial Hospital
    • Lancaster, Pennsylvania, United States, 17604-3555
      • Lancaster General Hospital
    • Langhorne, Pennsylvania, United States, 19047
      • Saint Mary Regional Center
    • Latrobe, Pennsylvania, United States, 15650
      • Latrobe Area Hospital
    • Lemoyne, Pennsylvania, United States, 17043
      • Central Pennsylvania Hematology and Medical Oncology Associates
    • Philadelphia, Pennsylvania, United States, 19141
      • Albert Einstein Cancer Center
    • Philadelphia, Pennsylvania, United States, 19102-1192
      • Hahnemann University Hospital
    • Philadelphia, Pennsylvania, United States, 19104-4283
      • University of Pennsylvania Cancer Center
    • Pittsburgh, Pennsylvania, United States, 15213
      • University of Pittsburgh Medical Center
    • Pittsburgh, Pennsylvania, United States, 15213-3180
      • Magee-Womens Hospital
    • Pittsburgh, Pennsylvania, United States, 15237
      • UPMC/Passavant Hospital
    • Pottstown, Pennsylvania, United States, 19464
      • Pottstown Memorial Regional Cancer Center
    • Reading, Pennsylvania, United States, 19612-6052
      • Reading Hospital and Medical Center
    • Scranton, Pennsylvania, United States, 18501
      • Mercy Hospital Cancer Center - Scranton
    • Scranton, Pennsylvania, United States, 18510
      • Moses Taylor Hospital
    • Scranton, Pennsylvania, United States, 18510
      • Scranton Hematology-Oncology
    • State College, Pennsylvania, United States, 16801
      • Geisinger Medical Group
    • West Chester, Pennsylvania, United States, 19380
      • Chester County Hospital
    • Wilkes-Barre, Pennsylvania, United States, 18711
      • Geisinger Wyoming Valley Medical Center
  • Rhode Island
    • Providence, Rhode Island, United States, 02903
      • Rhode Island Hospital
  • South Carolina
    • Greenville, South Carolina, United States, 29615
      • CCOP - Greenville
    • Spartanburg, South Carolina, United States, 29303
      • CCOP - Upstate Carolina
  • South Dakota
    • Rapid City, South Dakota, United States, 57709
      • Rapid City Regional Hospital
    • Sioux Falls, South Dakota, United States, 57105
      • Avera Cancer Institute
    • Sioux Falls, South Dakota, United States, 57117
      • Sioux Valley Hospital
    • Sioux Falls, South Dakota, United States, 57104
      • Sioux Valley Clinic
    • Sioux Falls, South Dakota, United States, 57105-1080
      • Avera McKennan Hospital and University Health Center
  • Tennessee
    • Memphis, Tennessee, United States, 38103
      • University of Tennessee, Memphis Cancer Center
    • Memphis, Tennessee, United States, 38104
      • Veterans Affairs Medical Center - Memphis
  • Texas
    • Fort Sam Houston, Texas, United States, 78234
      • Brooke Army Medical Center
    • Galveston, Texas, United States, 77555-0209
      • University of Texas Medical Branch
    • San Antonio, Texas, United States, 78284-7811
      • University of Texas Health Science Center at San Antonio
    • San Antonio, Texas, United States, 78284
      • Veterans Affairs Medical Center - San Antonio (Murphy)
    • Temple, Texas, United States, 76504
      • Veterans Affairs Medical Center - Temple
    • Temple, Texas, United States, 76508
      • CCOP - Scott and White Hospital
  • Utah
    • Salt Lake City, Utah, United States, 84148
      • Veterans Affairs Medical Center - Salt Lake City
    • Salt Lake City, Utah, United States, 84112
      • Huntsman Cancer Institute
  • Vermont
    • Burlington, Vermont, United States, 05401-3498
      • Vermont Cancer Center
    • White River Junction, Vermont, United States, 05009
      • Veterans Affairs Medical Center - White River Junction
  • Virginia
    • Richmond, Virginia, United States, 23298-0037
      • MBCCOP - Massey Cancer Center
    • Richmond, Virginia, United States, 23249
      • Veterans Affairs Medical Center - Richmond
  • Washington
    • Seattle, Washington, United States, 98101
      • CCOP - Virginia Mason Research Center
    • Seattle, Washington, United States, 98104
      • Swedish Cancer Institute
    • Seattle, Washington, United States, 98108
      • Veterans Affairs Medical Center - Seattle
    • Tacoma, Washington, United States, 98431-5000
      • Madigan Army Medical Center
    • Tacoma, Washington, United States, 98405-0986
      • CCOP - Northwest
  • Wisconsin
    • Appleton, Wisconsin, United States, 54911
      • Fox Valley Hematology and Oncology
    • Ashland, Wisconsin, United States, 54806
      • Memorial Medical Center
    • Eau Claire, Wisconsin, United States, 54703
      • Luther Hospital
    • Eau Claire, Wisconsin, United States, 54703
      • Midelfort Clinic
    • Green Bay, Wisconsin, United States, 54307-3508
      • St. Vincent Hospital
    • La Crosse, Wisconsin, United States, 54601
      • Gundersen Lutheran Medical Center
    • La Crosse, Wisconsin, United States, 54601-4796
      • Franciscan Skemp Healthcare
    • Madison, Wisconsin, United States, 53792-6164
      • University of Wisconsin Comprehensive Cancer Center
    • Madison, Wisconsin, United States, 53705
      • Veterans Affairs Medical Center - Madison
    • Madison, Wisconsin, United States, 53715
      • Meriter Hospital
    • Madison, Wisconsin, United States, 53715
      • Dean Medical Center
    • Marshfield, Wisconsin, United States, 54449
      • CCOP - Marshfield Medical Research and Education Foundation
    • Milwaukee, Wisconsin, United States, 53226
      • Medical College of Wisconsin
    • Milwaukee, Wisconsin, United States, 53295
      • Veterans Affairs Medical Center - Milwaukee (Zablocki)
    • Milwaukee, Wisconsin, United States, 53201-0342
      • Aurora Sinai Samaritan Medical Center
    • Oconomowoc, Wisconsin, United States, 53066
      • Oconomowoc Memorial Hospital
    • Waukesha, Wisconsin, United States, 53188
      • Waukesha Memorial Hospital
    • Wausau, Wisconsin, United States, 54401
      • UW Cancer Center Wausau Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed locally advanced, locally recurrent, or metastatic colorectal adenocarcinoma not curable by surgery or radiotherapy

  • Histological or cytological requirement waived in patients who developed radiological or clinical evidence of metastatic cancer after a prior surgical resection unless:

    • More than 5 years has elapsed since primary surgery OR
    • Primary cancer was stage I or II
• Site of primary lesion must be or have been confirmed endoscopically, radiologically, or surgically to be or have been in the large bowel
• Measurable or evaluable disease
• No CNS metastases or carcinomatous meningitis

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Performance status:

• ECOG 0-2

Life expectancy:

• At least 12 weeks

Hematopoietic:

• Absolute granulocyte count at least 1,500/mm^3
• Platelet count at least 100,000/mm^3
• Hemoglobin at least 9.0 g/dL (transfusion allowed)

Hepatic:

• Bilirubin no greater than 1.5 mg/dL
• AST no greater than 5 times upper limit of normal (ULN)
• Alkaline phosphatase no greater than 5 times ULN

Renal:

• Creatinine no greater than 1.5 times ULN

Cardiovascular:

• No uncontrolled hypertension
• No unstable angina
• No symptomatic congestive heart failure
• No myocardial infarction within the past 6 months
• No serious uncontrolled arrhythmia
• No New York Heart Association class III or IV cardiac disease

Pulmonary:

• No interstitial pneumonia or extensive and symptomatic interstitial fibrosis of the lung
• No pleural effusion or ascites that cause respiratory compromise (grade 2 or worse dyspnea)

Other:

• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• No active or uncontrolled infection
• No symptomatic sensory peripheral neuropathy
• No known allergy to platinum compounds
• No history of gastrointestinal bleeding unless it is determined to be acceptable by the enrolling physician
• No other prior or concurrent malignancy within the past 3 years except nonmelanoma skin cancer, carcinoma in situ of the uterine cervix, or other resected malignant tumor with less than a 10% probability of tumor relapse within 3 years of diagnosis
• No medical or psychiatric conditions that would preclude study
• No colonic or small bowel disorders with uncontrolled symptoms of more than 3 loose stools per day
• Colostomy or ileostomy allowed at investigator's discretion

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• Prior adjuvant immunotherapy for resected stage II-IV disease allowed if adjuvant therapy concluded at least 1 year before documentation of recurrent disease
• No concurrent sargramostim (GM-CSF)

Chemotherapy:

• No prior chemotherapy for advanced colorectal cancer
• No prior standard adjuvant chemotherapy for rectal cancer
• Prior adjuvant fluorouracil for resected stage II-IV disease allowed if adjuvant therapy concluded at least 1 year before documentation of recurrent disease

Radiotherapy:

• See Disease Characteristics
• At least 4 weeks since prior major radiotherapy (e.g., chest or bone palliative radiotherapy)
• No prior radiotherapy to more than 15% of bone marrow
• No prior standard adjuvant radiotherapy for rectal cancer

Surgery:

• See Disease Characteristics
• At least 4 weeks since prior major surgery (e.g., laparotomy) (2 weeks for minor surgery) and recovered
• Insertion of a vascular access device not considered major or minor surgery

Other:

• No other concurrent investigational agents

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: irinotecan + leucovorin + fluorouracil; Patients receive irinotecan IV over 90 minutes followed by leucovorin calcium IV over 15 minutes and fluorouracil IV once a week for 4 weeks followed by 2 weeks of rest. Courses repeat every 6 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity. Quality of life is assessed before treatment, during treatment (arm specific), and after completion of treatment. Patients are followed every 3 months for 1 year, every 6 months for 2 years, and then annually thereafter.	Drug: fluorouracil; Drug: leucovorin calcium; Drug: irinotecan
Experimental: oxaliplatin + leucovorin + fluorouracil; Patients receive oxaliplatin IV over 2 hours on day 1 and leucovorin calcium IV over 2 hours plus fluorouracil IV over 22 hours on days 1 and 2. Courses repeat every 2 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity. Quality of life is assessed before treatment, during treatment (arm specific), and after completion of treatment. Patients are followed every 3 months for 1 year, every 6 months for 2 years, and then annually thereafter.	Drug: fluorouracil; Drug: leucovorin calcium; Drug: oxaliplatin
Experimental: oxaliplatin + irinotecan; Patients receive oxaliplatin IV over 2 hours and irinotecan IV over 30 minutes on day 1. Courses repeat every 3 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity. Quality of life is assessed before treatment, during treatment (arm specific), and after completion of treatment. Patients are followed every 3 months for 1 year, every 6 months for 2 years, and then annually thereafter.	Drug: oxaliplatin; Drug: irinotecan

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
time to progression	Up to 5 years

Secondary Outcome Measures

Outcome Measure	Time Frame
response rate	Up to 5 years
overall survival	Up to 5 years
quality of life	Up to 5 years
time to treatment failure	Up to 5 years

Collaborators and Investigators

• Sponsor: Alliance for Clinical Trials in Oncology
• Collaborators: National Cancer Institute (NCI); NCIC Clinical Trials Group
• Investigators: Study Chair: Henry C. Pitot, MD, Mayo Clinic

Publications and helpful links

General Publications

• Franko J, Shi Q, Goldman CD, Pockaj BA, Nelson GD, Goldberg RM, Pitot HC, Grothey A, Alberts SR, Sargent DJ. Treatment of colorectal peritoneal carcinomatosis with systemic chemotherapy: a pooled analysis of north central cancer treatment group phase III trials N9741 and N9841. J Clin Oncol. 2012 Jan 20;30(3):263-7. doi: 10.1200/JCO.2011.37.1039. Epub 2011 Dec 12.
• An MW, Mandrekar SJ, Branda ME, Hillman SL, Adjei AA, Pitot HC, Goldberg RM, Sargent DJ. Comparison of continuous versus categorical tumor measurement-based metrics to predict overall survival in cancer treatment trials. Clin Cancer Res. 2011 Oct 15;17(20):6592-9. doi: 10.1158/1078-0432.CCR-11-0822. Epub 2011 Aug 31.
• Campbell ME, Mandrekar SJ, Hillman SL, et al.: What is the added value of actual tumor measurements (TM) in predicting overall survival (OS)? The North Central Cancer Treatment Group (NCCTG) findings. [Abstract] J Clin Oncol 26 (Suppl 15): A-6520, 2008.
• Grothey A, Hedrick EE, Mass RD, Sarkar S, Suzuki S, Ramanathan RK, Hurwitz HI, Goldberg RM, Sargent DJ. Response-independent survival benefit in metastatic colorectal cancer: a comparative analysis of N9741 and AVF2107. J Clin Oncol. 2008 Jan 10;26(2):183-9. doi: 10.1200/JCO.2007.13.8099.
• Grothey A, Hedrick EE, Mass RD, et al.: Response rate using conventional criteria is a poor surrogate for clinical benefit on progression-free (PFS) and overall survival (OS) in metastatic colorectal cancer (mCRC): a comparative analysis of N9741 and AVF2107. [Abstract] J Clin Oncol 24 (Suppl 18): A-3516, 2006.
• Goldberg R. Oxaliplatin in colorectal cancer: current studies. Oncology (Williston Park). 2000 Dec;14(12 Suppl 11):42-7.
• Heun JM, Grothey A, Branda ME, Goldberg RM, Sargent DJ. Tumor status at 12 weeks predicts survival in advanced colorectal cancer: findings from NCCTG N9741. Oncologist. 2011;16(6):859-67. doi: 10.1634/theoncologist.2011-0064. Epub 2011 May 31.
• Ng K, Sargent DJ, Goldberg RM, Meyerhardt JA, Green EM, Pitot HC, Hollis BW, Pollak MN, Fuchs CS. Vitamin D status in patients with stage IV colorectal cancer: findings from Intergroup trial N9741. J Clin Oncol. 2011 Apr 20;29(12):1599-606. doi: 10.1200/JCO.2010.31.7255. Epub 2011 Mar 21.
• Goldberg RM, Sargent DJ, McLeod H. Leveraging learning from a phase III colorectal cancer clinical trial: outcomes, methodology, meta-analysis and pharmacogenetics. Trans Am Clin Climatol Assoc. 2010;121:21-32; discussion 32-3.
• McLeod HL, Sargent DJ, Marsh S, Green EM, King CR, Fuchs CS, Ramanathan RK, Williamson SK, Findlay BP, Thibodeau SN, Grothey A, Morton RF, Goldberg RM. Pharmacogenetic predictors of adverse events and response to chemotherapy in metastatic colorectal cancer: results from North American Gastrointestinal Intergroup Trial N9741. J Clin Oncol. 2010 Jul 10;28(20):3227-33. doi: 10.1200/JCO.2009.21.7943. Epub 2010 Jun 7.
• Goldberg RM, Sargent DJ, Morton RF, Green E, Sanoff HK, McLeod H, Buckner J. NCCTG Study N9741: leveraging learning from an NCI Cooperative Group phase III trial. Oncologist. 2009 Oct;14(10):970-8. doi: 10.1634/theoncologist.2009-0175. Epub 2009 Oct 14.
• Sanoff HK, Sargent DJ, Green EM, McLeod HL, Goldberg RM. Racial differences in advanced colorectal cancer outcomes and pharmacogenetics: a subgroup analysis of a large randomized clinical trial. J Clin Oncol. 2009 Sep 1;27(25):4109-15. doi: 10.1200/JCO.2009.21.9527. Epub 2009 Jul 27.
• Fuchs CS, Goldberg RM, Sargent DJ, Meyerhardt JA, Wolpin BM, Green EM, Pitot HC, Pollak M. Plasma insulin-like growth factors, insulin-like binding protein-3, and outcome in metastatic colorectal cancer: results from intergroup trial N9741. Clin Cancer Res. 2008 Dec 15;14(24):8263-9. doi: 10.1158/1078-0432.CCR-08-0480. Epub 2008 Dec 10.
• Sanoff HK, Sargent DJ, Campbell ME, Morton RF, Fuchs CS, Ramanathan RK, Williamson SK, Findlay BP, Pitot HC, Goldberg RM. Five-year data and prognostic factor analysis of oxaliplatin and irinotecan combinations for advanced colorectal cancer: N9741. J Clin Oncol. 2008 Dec 10;26(35):5721-7. doi: 10.1200/JCO.2008.17.7147. Epub 2008 Nov 10.
• Sargent DJ, Campbell M, Grothey A, et al.: Overall and 12 week tumor response versus actual tumor measurements as predictors of overall survival (OS) in advanced colorectal cancer (ACRC): findings from NCCTG N9741. [Abstract] American Society of Clinical Oncology 2008 Gastrointestinal Cancers Symposium, 25-27 January 2008, Orlando, FL. A-446, 2008.
• Dy GK, Krook JE, Green EM, Sargent DJ, Delaunoit T, Morton RF, Fuchs CS, Ramanathan RK, Williamson SK, Findlay BP, Pockaj BA, Sticca RP, Alberts SR, Pitot HC 4th, Goldberg RM; Intergroup N9741. Impact of complete response to chemotherapy on overall survival in advanced colorectal cancer: results from Intergroup N9741. J Clin Oncol. 2007 Aug 10;25(23):3469-74. doi: 10.1200/JCO.2007.10.7128. Erratum In: J Clin Oncol. 2007 Nov 20;25(33):5339.
• Grothey A, Sargent DJ, Campbell ME, et al.: Waterfall plots provide detailed information on magnitude of response to conventional chemotherapy in colorectal cancer: lessons learned from N9741. [Abstract] American Society of Clinical Oncology 2007 Gastrointestinal Cancers Symposium, 19 -21 January 2007, Orlando, Florida A-337, 2007.
• Goldberg RM, McLeod HL, Sargent DJ, et al.: Genetic polymorphisms, toxicity, and response rate in African Americans (AA) with metastatic colorectal cancer (MCRC) compared to Caucasians (C) when treated with IFL, FOLFOX or IROX in Intergroup N9741. [Abstract] J Clin Oncol 24 (Suppl 18): A-3503, 2006.
• Goldberg RM, Sargent DJ, Morton RF, Fuchs CS, Ramanathan RK, Williamson SK, Findlay BP, Pitot HC, Alberts S. Randomized controlled trial of reduced-dose bolus fluorouracil plus leucovorin and irinotecan or infused fluorouracil plus leucovorin and oxaliplatin in patients with previously untreated metastatic colorectal cancer: a North American Intergroup Trial. J Clin Oncol. 2006 Jul 20;24(21):3347-53. doi: 10.1200/JCO.2006.06.1317.
• McLeod HL, Parodi L, Sargent DJ, et al.: UGT1A1*28, toxicity and outcome in advanced colorectal cancer: results from trial N9741. [Abstract] J Clin Oncol 24 (Suppl 18): A-3520, 2006.
• Delaunoit T, Alberts SR, Sargent DJ, Green E, Goldberg RM, Krook J, Fuchs C, Ramanathan RK, Williamson SK, Morton RF, Findlay BP. Chemotherapy permits resection of metastatic colorectal cancer: experience from Intergroup N9741. Ann Oncol. 2005 Mar;16(3):425-9. doi: 10.1093/annonc/mdi092. Epub 2005 Jan 27.
• Delaunoit T, Goldberg RM, Sargent DJ, Morton RF, Fuchs CS, Findlay BP, Thomas SP, Salim M, Schaefer PL, Stella PJ, Green E, Mailliard JA. Mortality associated with daily bolus 5-fluorouracil/leucovorin administered in combination with either irinotecan or oxaliplatin: results from Intergroup Trial N9741. Cancer. 2004 Nov 15;101(10):2170-6. doi: 10.1002/cncr.20594.
• Goldberg RM, Sargent DJ, Morton RF, Fuchs CS, Ramanathan RK, Williamson SK, Findlay BP, Pitot HC, Alberts SR. A randomized controlled trial of fluorouracil plus leucovorin, irinotecan, and oxaliplatin combinations in patients with previously untreated metastatic colorectal cancer. J Clin Oncol. 2004 Jan 1;22(1):23-30. doi: 10.1200/JCO.2004.09.046. Epub 2003 Dec 9.
• Goldberg RM, Morton RF, Sargent DJ, et al.: N9741: oxaliplatin (Oxal) or CPT-11 + 5-fluorouracil (5FU)/leucovorin (LV) or oxal + CPT-11 in advanced colorectal cancer (CRC). Updated efficacy and quality of life (QOL) data from an intergroup study. [Abstract] Proceedings of the American Society of Clinical Oncology 22: A-1009, 252, 2003.
• Goldberg RM, Morton RF, Sargent D, et al.: N9741: oxaliplatin (oxal) or CPT-11 + 5-fluorouracil (5FU)/leucovorin (LV) or oxal + CPT-11 in advanced colorectal cancer (CRC). Initial toxicity and response data from a GI Intergroup study. [Abstract] Proceedings of the American Society of Clinical Oncology 21: A-511, 2002.
• Morton RF, Goldberg RM, Sargent DJ, et al.: Oxaliplatin (OXAL) or CPT-11 Combined with 5FU/Leucovorin (LV) in Advanced Colorectal Cancer (CRC): an NCCTG/CALGB Study. [Abstract] Proceedings of the American Society of Clinical Oncology 20: A-495, 2001.
• Yuan C, Renfro L, Ambadwar PB, Ou FS, McLeod HL, Innocenti F, Meyerhardt JA, Wolpin BM, Goldberg RM, Grothey A, Fuchs CS, Ng K. Influence of genetic variation in the vitamin D pathway on plasma 25-hydroxyvitamin D3 levels and survival among patients with metastatic colorectal cancer. Cancer Causes Control. 2019 Jul;30(7):757-765. doi: 10.1007/s10552-019-01183-1. Epub 2019 May 18.

Helpful Links

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

Study record dates

Study Major Dates

• Study Start: October 1, 1998
• Primary Completion (Actual): October 1, 2004
• Study Completion (Actual): October 1, 2004

Study Registration Dates

• First Submitted: November 1, 1999
• First Submitted That Met QC Criteria: September 24, 2003
• First Posted (Estimate): September 25, 2003

Study Record Updates

• Last Update Posted (Actual): April 29, 2020
• Last Update Submitted That Met QC Criteria: April 28, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: adenocarcinoma of the rectum; stage IV rectal cancer; stage IV colon cancer; adenocarcinoma of the colon; recurrent colon cancer; recurrent rectal cancer; stage III colon cancer; stage III rectal cancer
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Protective Agents; Topoisomerase Inhibitors; Micronutrients; Vitamins; Calcium-Regulating Hormones and Agents; Topoisomerase I Inhibitors; Antidotes; Vitamin B Complex; Fluorouracil; Oxaliplatin; Leucovorin; Irinotecan; Calcium; Levoleucovorin
• Other Study ID Numbers: NCCTG-N9741; CDR0000066665 (Registry Identifier: PDQ (Physician Data Query)); CAN-NCIC-CO13