Selumetinib and Akt Inhibitor MK2206 or mFOLFOX Therapy Comprising Oxaliplatin and Fluorouracil in Treating Patients With Metastatic Pancreatic Cancer Previously Treated With Chemotherapy (S1115)

February 10, 2016 updated by: National Cancer Institute (NCI)

Randomized Phase II Clinical Trial of AZD6244 Hydrogen Sulfate (NSC-748727) and MK-2206 (NSC-749607) vs mFOLFOX in Patients With Metastatic Pancreatic Cancer After Prior Chemotherapy

This randomized phase II trial studies how well selumetinib and Akt inhibitor MK2206 work compared to modified fluorouracil, leucovorin calcium, and oxaliplatin (mFOLFOX) therapy in treating patients with metastatic pancreatic cancer previously treated with chemotherapy. Selumetinib and Akt inhibitor MK2206 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as oxaliplatin, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet know whether selumetinib and Akt inhibitor MK2206 are more effective than oxaliplatin and fluorouracil in treating patients with metastatic pancreatic cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

PRIMARY OBJECTIVES:

I. To assess overall survival in patients with metastatic pancreatic cancer treated with the combination of AZD6244 hydrogen sulfate (selumetinib) and MK-2206 (Akt inhibitor MK2206) compared to those treated with mFOLFOX.

SECONDARY OBJECTIVES:

I. To assess the frequency and severity of toxicity associated with the combination of AZD6244 hydrogen sulfate and MK-2206 compared to those with mFOLFOX in this patient population.

TERTIARY OBJECTIVES:

I. To assess progression free survival (PFS) in patients with metastatic pancreatic cancer treated with the combination of AZD6244 hydrogen sulfate and MK-2206 compared to those treated with mFOLFOX.

II. To assess objective tumor response in the subset of patients with measurable disease (confirmed and unconfirmed complete and partial response) in patients with metastatic pancreatic cancer treated with the combination of AZD6244 hydrogen sulfate and MK-2206 compared to those treated with mFOLFOX.

III. To bank tissue and blood for future translational medicine studies.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive oxaliplatin intravenously (IV) over 2 hours on days 1 and 15 and fluorouracil IV over 46-48 hours on days 1-2 and 15-16 (mFOLFOX).

ARM II: Patients receive Akt inhibitor MK2206 orally (PO) on days 1, 8, 15, and 22, and selumetinib PO daily on days 1-28.

In all arms, courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 6 months for up to 3 years.

Study Type

Interventional

Enrollment (Actual)

137

Phase

Phase 2

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

United States
- Arizona
  - Tucson, Arizona, United States, 85719
    - The University of Arizona Cancer Center-North Campus
  - Tucson, Arizona, United States, 85704
    - The University of Arizona Cancer Center-Orange Grove Campus
- Arkansas
  - Little Rock, Arkansas, United States, 72205
    - University of Arkansas for Medical Sciences
- California
  - Anaheim, California, United States, 92807
    - Kaiser Permanente-Anaheim
  - Antioch, California, United States, 94531
    - Kaiser Permanente-Deer Valley Medical Center
  - Baldwin Park, California, United States, 91706
    - Kaiser Permanente-Baldwin Park
  - Bellflower, California, United States, 90706
    - Kaiser Permanente-Bellflower
  - Berkeley, California, United States, 94704
    - Alta Bates Summit Medical Center-Herrick Campus
  - Burlingame, California, United States, 94010
    - Mills - Peninsula Hospitals
  - Castro Valley, California, United States, 94546
    - East Bay Radiation Oncology Center
  - Castro Valley, California, United States, 94546
    - Valley Medical Oncology Consultants-Castro Valley
  - Duarte, California, United States, 91010
    - City of Hope Comprehensive Cancer Center
  - Dublin, California, United States, 94568
    - Epic Care-Dublin
  - Emeryville, California, United States, 94608
    - Bay Area Breast Surgeons Inc
  - Emeryville, California, United States, 94608
    - Epic Care Partners in Cancer Care
  - Fontana, California, United States, 92335
    - Kaiser Permanente Hospital
  - Fremont, California, United States, 94538
    - Kaiser Permanente-Fremont
  - Fremont, California, United States, 94538
    - Valley Medical Oncology Consultants-Fremont
  - Fresno, California, United States, 93720
    - Kaiser Permanente
  - Fullerton, California, United States, 92835
    - Saint Jude Medical Center
  - Harbor City, California, United States, 90710
    - Kaiser Permanente - Harbor City
  - Irvine, California, United States, 92618
    - Kaiser Permanente-Irvine
  - Los Angeles, California, United States, 90033
    - USC / Norris Comprehensive Cancer Center
  - Los Angeles, California, United States, 90048
    - Cedars-Sinai Medical Center
  - Los Angeles, California, United States, 90033
    - Los Angeles County-USC Medical Center
  - Los Angeles, California, United States, 90027
    - Kaiser Permanente Los Angeles Medical Center
  - Los Angeles, California, United States, 90034
    - Kaiser Permanente-Cadillac
  - Martinez, California, United States, 94553-3156
    - Contra Costa Regional Medical Center
  - Marysville, California, United States, 95901
    - Fremont - Rideout Cancer Center
  - Merced, California, United States, 95340
    - Mercy UC Davis Cancer Center
  - Modesto, California, United States, 95356
    - Kaiser Permanente-Modesto
  - Mountain View, California, United States, 94040
    - El Camino Hospital
  - Novato, California, United States, 94945
    - Sutter Cancer Research Consortium
  - Oakland, California, United States, 94611
    - Kaiser Permanente-Oakland
  - Oakland, California, United States, 94609
    - Alta Bates Summit Medical Center - Summit Campus
  - Oakland, California, United States, 94609
    - Hematology and Oncology Associates-Oakland
  - Oakland, California, United States, 94602
    - Highland General Hospital
  - Oakland, California, United States, 94609
    - Tom K Lee Inc
  - Oakland, California, United States, 94609
    - Bay Area Tumor Institute
  - Orange, California, United States, 92868
    - UC Irvine Health/Chao Family Comprehensive Cancer Center
  - Orange, California, United States, 92868
    - Saint Joseph Hospital - Orange
  - Panorama City, California, United States, 91402
    - Kaiser Permanente - Panorama City
  - Pleasant Hill, California, United States, 94523
    - East Bay Medical Oncology Hematology Medical Associates Inc-Pleasant Hill
  - Pleasanton, California, United States, 94588
    - Valley Medical Oncology Consultants
  - Redwood City, California, United States, 94063
    - Kaiser Permanente-Redwood City
  - Richmond, California, United States, 94801
    - Kaiser Permanente-Richmond
  - Riverside, California, United States, 92505
    - Kaiser Permanente-Riverside
  - Roseville, California, United States, 95661
    - Kaiser Permanente-Roseville
  - Sacramento, California, United States, 95817
    - University of California Davis Comprehensive Cancer Center
  - Sacramento, California, United States, 95823
    - Kaiser Permanente-South Sacramento
  - Sacramento, California, United States, 95825
    - Kaiser Permanente - Sacramento
  - Saint Helena, California, United States, 94574
    - Saint Helena Hospital
  - San Diego, California, United States, 92120
    - Kaiser Permanente-San Diego Zion
  - San Diego, California, United States, 92108
    - Kaiser Permanente-San Diego Mission
  - San Francisco, California, United States, 94115
    - Kaiser Permanente-San Francisco
  - San Francisco, California, United States, 94118
    - California Pacific Medical Center-Pacific Campus
  - San Jose, California, United States, 95119
    - Kaiser Permanente-Santa Teresa-San Jose
  - San Leandro, California, United States, 94577
    - Kaiser Permanente San Leandro
  - San Marcos, California, United States, 92069
    - Kaiser Permanente-San Marcos
  - San Pablo, California, United States, 94806
    - Doctors Medical Center- JC Robinson Regional Cancer Center
  - San Rafael, California, United States, 94903
    - Kaiser Permanente-San Rafael
  - Santa Clara, California, United States, 95051
    - Kaiser Permanente Medical Center - Santa Clara
  - Santa Rosa, California, United States, 95403
    - Kaiser Permanente-Santa Rosa
  - Santa Rosa, California, United States, 95403
    - Sutter Pacific Medical Foundation
  - South San Francisco, California, United States, 94080
    - Kaiser Permanente-South San Francisco
  - Stockton, California, United States, 95210
    - Kaiser Permanente-Stockton
  - Truckee, California, United States, 96161
    - Tahoe Forest Cancer Center
  - Vacaville, California, United States, 95688
    - Kaiser Permanente Medical Center-Vacaville
  - Vallejo, California, United States, 94589
    - Kaiser Permanente-Vallejo
  - Vallejo, California, United States, 94589
    - Sutter Solano Medical Center/Cancer Center
  - Walnut Creek, California, United States, 94596
    - Kaiser Permanente-Walnut Creek
  - Woodland Hills, California, United States, 91367
    - Kaiser Permanente
- Colorado
  - Aurora, Colorado, United States, 80012
    - The Medical Center of Aurora
  - Boulder, Colorado, United States, 80301
    - Boulder Community Hospital
  - Boulder, Colorado, United States, 80304
    - Rocky Mountain Cancer Centers-Boulder
  - Colorado Springs, Colorado, United States, 80907
    - Penrose-Saint Francis Healthcare
  - Colorado Springs, Colorado, United States, 80907
    - Rocky Mountain Cancer Centers-Penrose
  - Denver, Colorado, United States, 80210
    - Porter Adventist Hospital
  - Denver, Colorado, United States, 80205
    - Kaiser Permanente-Franklin
  - Denver, Colorado, United States, 80218
    - Presbyterian - Saint Lukes Medical Center - Health One
  - Denver, Colorado, United States, 80220
    - Rose Medical Center
  - Denver, Colorado, United States, 80218
    - Exempla Saint Joseph Hospital
  - Denver, Colorado, United States, 80218
    - Rocky Mountain Cancer Centers-Midtown
  - Denver, Colorado, United States, 80220
    - Rocky Mountain Cancer Centers-Rose
  - Denver, Colorado, United States, 80218
    - Colorado Blood Cancer Institute
  - Denver, Colorado, United States, 80224-2522
    - Colorado Cancer Research Program CCOP
  - Durango, Colorado, United States, 81301
    - Mercy Medical Center
  - Englewood, Colorado, United States, 80113
    - Swedish Medical Center
  - Englewood, Colorado, United States, 80113
    - Comprehensive Cancer Care and Research Institute of Colorado LLC
  - Fort Collins, Colorado, United States, 80524
    - Poudre Valley Hospital
  - Fort Collins, Colorado, United States, 80528
    - Front Range Cancer Specialists
  - Golden, Colorado, United States, 80401
    - Mountain Blue Cancer Care Center
  - Greeley, Colorado, United States, 80631
    - North Colorado Medical Center
  - Greenwood Village, Colorado, United States, 80111
    - Rocky Mountain Cancer Centers-Greenwood Village
  - Lafayette, Colorado, United States, 80026
    - Kaiser Permanente-Rock Creek
  - Lakewood, Colorado, United States, 80228
    - Saint Anthony Hospital
  - Lakewood, Colorado, United States, 80228
    - Rocky Mountain Cancer Centers-Lakewood
  - Littleton, Colorado, United States, 80122
    - Littleton Adventist Hospital
  - Lone Tree, Colorado, United States, 80124
    - Kaiser Permanente-Lone Tree
  - Lone Tree, Colorado, United States, 80124
    - Sky Ridge Medical Center
  - Lone Tree, Colorado, United States, 80124
    - Rocky Mountain Cancer Centers-Sky Ridge
  - Longmont, Colorado, United States, 80501
    - Longmont United Hospital
  - Longmont, Colorado, United States, 80501
    - Rocky Mountain Cancer Centers-Longmont
  - Loveland, Colorado, United States, 80539
    - McKee Medical Center
  - Parker, Colorado, United States, 80138
    - Parker Adventist Hospital
  - Parker, Colorado, United States, 80138
    - Rocky Mountain Cancer Centers-Parker
  - Pueblo, Colorado, United States, 81004
    - Saint Mary Corwin Medical Center
  - Pueblo, Colorado, United States, 81008
    - Rocky Mountain Cancer Centers - Pueblo
  - Wheat Ridge, Colorado, United States, 80033
    - SCL Health Lutheran Medical Center
- Connecticut
  - Hartford, Connecticut, United States, 06105
    - Saint Francis Hospital and Medical Center
  - Middletown, Connecticut, United States, 06457
    - Middlesex Hospital
  - Stamford, Connecticut, United States, 06904
    - Stamford Hospital/Bennett Cancer Center
- Delaware
  - Lewes, Delaware, United States, 19958
    - Beebe Medical Center
  - Newark, Delaware, United States, 19713
    - Helen F Graham Cancer Center
  - Newark, Delaware, United States, 19713
    - Delaware Clinical and Laboratory Physicians PA
  - Newark, Delaware, United States, 19713
    - Medical Oncology Hematology Consultants PA
  - Newark, Delaware, United States, 19718
    - Christiana Care Health System-Christiana Hospital
  - Newark, Delaware, United States, 19713
    - Christiana Gynecologic Oncology LLC
  - Newark, Delaware, United States, 19713
    - Regional Hematology and Oncology PA
  - Rehoboth Beach, Delaware, United States, 19971
    - Beebe Health Campus
  - Seaford, Delaware, United States, 19973
    - Nanticoke Memorial Hospital
  - Wilmington, Delaware, United States, 19801
    - Christiana Care Health System-Wilmington Hospital
- Florida
  - Jacksonville, Florida, United States, 32207
    - Baptist Cancer Institute
  - Orlando, Florida, United States, 32803
    - Florida Hospital Orlando
- Georgia
  - Athens, Georgia, United States, 30607
    - University Cancer and Blood Center LLC
  - Augusta, Georgia, United States, 30912
    - Georgia Regents University Medical Center
  - Decatur, Georgia, United States, 30033
    - Dekalb Medical Center
  - Gainesville, Georgia, United States, 30501
    - Northeast Georgia Medical Center
  - Macon, Georgia, United States, 31208
    - Medical Center of Central Georgia
  - Savannah, Georgia, United States, 31405
    - Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
  - Valdosta, Georgia, United States, 31603
    - South Georgia Medical Center
- Hawaii
  - Aiea, Hawaii, United States, 96701
    - Oncare Hawaii Inc-Pali Momi
  - Aiea, Hawaii, United States, 96701
    - Pali Momi Medical Center
  - Honolulu, Hawaii, United States, 96813
    - Queen's Medical Center
  - Honolulu, Hawaii, United States, 96813
    - Straub Clinic and Hospital
  - Honolulu, Hawaii, United States, 96813
    - University of Hawaii Cancer Center
  - Honolulu, Hawaii, United States, 96819
    - Kaiser Permanente Moanalua Medical Center
  - Honolulu, Hawaii, United States, 96813
    - Oncare Hawaii Inc-POB II
  - Honolulu, Hawaii, United States, 96817-3169
    - OnCare Hawaii-Liliha
  - Honolulu, Hawaii, United States, 96817
    - Oncare Hawaii Inc-Kuakini
  - Kailua, Hawaii, United States, 96734
    - Castle Medical Center
  - Lihue, Hawaii, United States, 96766
    - Wilcox Memorial Hospital and Kauai Medical Clinic
- Idaho
  - Boise, Idaho, United States, 83706
    - Saint Alphonsus Cancer Care Center-Boise
  - Meridian, Idaho, United States, 83642
    - Idaho Urologic Institute-Meridian
  - Post Falls, Idaho, United States, 83854
    - Kootenai Cancer Center
- Illinois
  - Aurora, Illinois, United States, 60504
    - Rush - Copley Medical Center
  - Carbondale, Illinois, United States, 62902
    - Memorial Hospital of Carbondale
  - Centralia, Illinois, United States, 62801
    - Centralia Oncology Clinic
  - Chicago, Illinois, United States, 60611
    - Northwestern University
  - Chicago, Illinois, United States, 60612
    - Rush University Medical Center
  - Chicago, Illinois, United States, 60637
    - University of Chicago Comprehensive Cancer Center
  - Chicago, Illinois, United States, 60612
    - University of Illinois
  - Chicago, Illinois, United States, 60640
    - Weiss Memorial Hospital
  - Decatur, Illinois, United States, 62526
    - Decatur Memorial Hospital
  - Decatur, Illinois, United States, 62526
    - Cancer Care Center of Decatur
  - Decatur, Illinois, United States, 62526
    - Central Illinois CCOP
  - Effingham, Illinois, United States, 62401
    - Crossroads Cancer Center
  - Elgin, Illinois, United States, 60123
    - Advocate Sherman Hospital
  - Harvey, Illinois, United States, 60426
    - Ingalls Memorial Hospital
  - Highland Park, Illinois, United States, 60035
    - Hematology Oncology Associates of Illinois-Highland Park
  - Joliet, Illinois, United States, 60435
    - Joliet Oncology-Hematology Associates Limited
  - Kankakee, Illinois, United States, 60901
    - Presence Saint Mary's Hospital
  - Libertyville, Illinois, United States, 60048
    - NorthShore Hematology Oncology-Libertyville
  - Maywood, Illinois, United States, 60153
    - Loyola University Medical Center
  - Mount Vernon, Illinois, United States, 62864
    - Good Samaritan Regional Health Center
  - Niles, Illinois, United States, 60714
    - Illinois Cancer Specialists-Niles
  - River Forest, Illinois, United States, 60305
    - West Suburban Medical Center
  - Skokie, Illinois, United States, 60076
    - Hematology Oncology Associates of Illinois - Skokie
  - Springfield, Illinois, United States, 62781
    - Memorial Medical Center
  - Urbana, Illinois, United States, 61801
    - Carle Cancer Center
- Indiana
  - Beech Grove, Indiana, United States, 46107
    - Franciscan St. Francis Health-Beech Grove
  - Elkhart, Indiana, United States, 46515
    - Elkhart General Hospital
  - Elkhart, Indiana, United States, 46514
    - Michiana Hematology Oncology PC-Elkhart
  - Elkhart, Indiana, United States, 46514-2098
    - Elkhart Clinic
  - Fort Wayne, Indiana, United States, 46845
    - Fort Wayne Medical Oncology and Hematology Inc-Parkview
  - Indianapolis, Indiana, United States, 46202
    - Indiana University/Melvin and Bren Simon Cancer Center
  - Indianapolis, Indiana, United States, 46219
    - IU Health Central Indiana Cancer Centers-East
  - Indianapolis, Indiana, United States, 46237
    - Franciscan Saint Francis Health-Indianapolis
  - Kokomo, Indiana, United States, 46904
    - Community Howard Regional Health
  - La Porte, Indiana, United States, 46350
    - IU Health La Porte Hospital
  - Michigan City, Indiana, United States, 46360
    - Franciscan Saint Anthony Health-Michigan City
  - Mishawaka, Indiana, United States, 46545
    - Michiana Hematology Oncology PC-Mishawaka
  - Mishawaka, Indiana, United States, 46545
    - Cancer Care Partners LLC
  - Mishawaka, Indiana, United States, 46545
    - Saint Joseph Regional Medical Center-Mishawaka
  - Plymouth, Indiana, United States, 46563
    - Michiana Hematology Oncology PC-Plymouth
  - Richmond, Indiana, United States, 47374
    - Reid Hospital and Health Care Services
  - South Bend, Indiana, United States, 46601
    - Memorial Hospital of South Bend
  - South Bend, Indiana, United States, 46601
    - Michiana Hematology Oncology PC-South Bend
  - South Bend, Indiana, United States, 46617
    - South Bend Clinic
  - South Bend, Indiana, United States, 46628
    - Northern Indiana Cancer Research Consortium CCOP
  - Westville, Indiana, United States, 46391
    - Michiana Hematology Oncology PC-Westville
- Iowa
  - Bettendorf, Iowa, United States, 52722
    - Hematology Oncology Associates-Quad Cities
  - Davenport, Iowa, United States, 52803
    - Genesis Medical Center - East Campus
  - Sioux City, Iowa, United States, 51101
    - Siouxland Regional Cancer Center
  - Sioux City, Iowa, United States, 51104
    - Saint Luke's Regional Medical Center
  - Sioux City, Iowa, United States, 51104
    - Mercy Medical Center-Sioux City
- Kansas
  - Chanute, Kansas, United States, 66720
    - Cancer Center of Kansas - Chanute
  - Dodge City, Kansas, United States, 67801
    - Cancer Center of Kansas - Dodge City
  - El Dorado, Kansas, United States, 67042
    - Cancer Center of Kansas - El Dorado
  - Fort Scott, Kansas, United States, 66701
    - Cancer Center of Kansas - Fort Scott
  - Independence, Kansas, United States, 67301
    - Cancer Center of Kansas-Independence
  - Kansas City, Kansas, United States, 66112
    - Providence Medical Center
  - Kingman, Kansas, United States, 67068
    - Cancer Center of Kansas-Kingman
  - Lawrence, Kansas, United States, 66044
    - Lawrence Memorial Hospital
  - Liberal, Kansas, United States, 67901
    - Cancer Center of Kansas-Liberal
  - Manhattan, Kansas, United States, 66502
    - Cancer Center of Kansas-Manhattan
  - McPherson, Kansas, United States, 67460
    - Cancer Center of Kansas - McPherson
  - Newton, Kansas, United States, 67114
    - Cancer Center of Kansas - Newton
  - Overland Park, Kansas, United States, 66209
    - Menorah Medical Center
  - Overland Park, Kansas, United States, 66213
    - Saint Luke's South Hospital
  - Parsons, Kansas, United States, 67357
    - Cancer Center of Kansas - Parsons
  - Prairie Village, Kansas, United States, 66208
    - Kansas City CCOP
  - Pratt, Kansas, United States, 67124
    - Cancer Center of Kansas - Pratt
  - Salina, Kansas, United States, 67401
    - Cancer Center of Kansas - Salina
  - Wellington, Kansas, United States, 67152
    - Cancer Center of Kansas - Wellington
  - Wichita, Kansas, United States, 67208
    - Cancer Center of Kansas-Wichita Medical Arts Tower
  - Wichita, Kansas, United States, 67208
    - Associates In Womens Health
  - Wichita, Kansas, United States, 67214
    - Cancer Center of Kansas - Main Office
  - Wichita, Kansas, United States, 67214
    - Via Christi Regional Medical Center
  - Wichita, Kansas, United States, 67214
    - Wichita CCOP
  - Winfield, Kansas, United States, 67156
    - Cancer Center of Kansas - Winfield
- Kentucky
  - Crestview Hills, Kentucky, United States, 41017
    - Oncology Hematology Care Inc-Crestview
- Louisiana
  - Baton Rouge, Louisiana, United States, 70809
    - Mary Bird Perkins Cancer Center
  - Baton Rouge, Louisiana, United States, 70809
    - Ochsner Health Center-Summa
  - Baton Rouge, Louisiana, United States, 70809
    - Hematology/Oncology Clinic LLP
  - Lafayette, Louisiana, United States, 70503
    - Cancer Center of Acadiana
  - Mansfield, Louisiana, United States, 71052
    - DeSoto Regional Health System
  - Monroe, Louisiana, United States, 71202
    - University Health-Conway
  - New Orleans, Louisiana, United States, 70121
    - Ochsner Medical Center Jefferson
  - New Orleans, Louisiana, United States, 70112
    - Tulane University Health Sciences Center
  - New Orleans, Louisiana, United States, 70112
    - Louisiana State University Health Science Center
  - New Orleans, Louisiana, United States, 70115
    - Ochsner Baptist Medical Center
  - Shreveport, Louisiana, United States, 71103
    - Louisiana State University Health Sciences Center Shreveport
  - Shreveport, Louisiana, United States, 71105
    - Highland Clinic
- Maine
  - Augusta, Maine, United States, 04330
    - Harold Alfond Center for Cancer Care
  - Bangor, Maine, United States, 04401
    - Eastern Maine Medical Center
- Maryland
  - Elkton MD, Maryland, United States, 21921
    - Union Hospital of Cecil County
- Michigan
  - Adrian, Michigan, United States, 49221
    - Bixby Medical Center
  - Adrian, Michigan, United States, 49221
    - Hickman Cancer Center
  - Ann Arbor, Michigan, United States, 48106-0995
    - Saint Joseph Mercy Hospital
  - Ann Arbor, Michigan, United States, 48106
    - Michigan Cancer Research Consortium CCOP
  - Ann Arbor, Michigan, United States, 48109
    - University of Michigan Comprehensive Cancer Center
  - Battle Creek, Michigan, United States, 49017
    - Bronson Battle Creek
  - Big Rapids, Michigan, United States, 49307
    - Spectrum Health Big Rapids Hospital
  - Commerce, Michigan, United States, 48382
    - Huron Valley-Sinai Hospital
  - Dearborn, Michigan, United States, 48124
    - Oakwood Hospital and Medical Center
  - Detroit, Michigan, United States, 48236
    - Saint John Hospital and Medical Center
  - Detroit, Michigan, United States, 48201
    - Wayne State University/Karmanos Cancer Institute
  - Flint, Michigan, United States, 48502
    - Hurley Medical Center
  - Flint, Michigan, United States, 48503
    - Genesys Hurley Cancer Institute
  - Grand Blanc, Michigan, United States, 48439
    - Genesys Regional Medical Center
  - Grand Rapids, Michigan, United States, 49503
    - Spectrum Health at Butterworth Campus
  - Grand Rapids, Michigan, United States, 49503
    - Mercy Health Saint Mary's
  - Grand Rapids, Michigan, United States, 49503
    - Grand Rapids Clinical Oncology Program
  - Jackson, Michigan, United States, 49201
    - Allegiance Health
  - Kalamazoo, Michigan, United States, 49007
    - West Michigan Cancer Center
  - Kalamazoo, Michigan, United States, 49007
    - Bronson Methodist Hospital
  - Kalamazoo, Michigan, United States, 49001
    - Borgess Medical Center
  - Lansing, Michigan, United States, 48912
    - Sparrow Hospital
  - Livonia, Michigan, United States, 48154
    - Saint Mary Mercy Hospital
  - Monroe, Michigan, United States, 48162
    - Mercy Memorial Hospital
  - Monroe, Michigan, United States, 48162
    - Toledo Clinic Cancer Centers-Monroe
  - Muskegon, Michigan, United States, 49444
    - Mercy Health Mercy Campus
  - Pontiac, Michigan, United States, 48341
    - Saint Joseph Mercy Oakland
  - Port Huron, Michigan, United States, 48060
    - Saint Joseph Mercy Port Huron
  - Reed City, Michigan, United States, 49677
    - Spectrum Health Reed City Hospital
  - Saginaw, Michigan, United States, 48601
    - Saint Mary's of Michigan
  - Saint Joseph, Michigan, United States, 49085
    - Marie Yeager Cancer Center
  - Southfield, Michigan, United States, 48075
    - Providence Hospital-Southfield Cancer Center
  - St. Joseph, Michigan, United States, 49085
    - Lakeland Hospital
  - Traverse City, Michigan, United States, 49684
    - Munson Medical Center
  - Warren, Michigan, United States, 48093
    - Saint John Macomb-Oakland Hospital
- Minnesota
  - Bemidji, Minnesota, United States, 56601
    - Sanford Clinic North-Bemidgi
  - Burnsville, Minnesota, United States, 55337
    - Fairview Ridges Hospital
  - Coon Rapids, Minnesota, United States, 55433
    - Mercy Hospital
  - Edina, Minnesota, United States, 55435
    - Fairview-Southdale Hospital
  - Fridley, Minnesota, United States, 55432
    - Unity Hospital
  - Hutchinson, Minnesota, United States, 55350
    - Hutchinson Area Health Care
  - Maplewood, Minnesota, United States, 55109
    - Saint John's Hospital - Healtheast
  - Maplewood, Minnesota, United States, 55109
    - Minnesota Oncology Hematology PA-Maplewood
  - Minneapolis, Minnesota, United States, 55415
    - Hennepin County Medical Center
  - Minneapolis, Minnesota, United States, 55407
    - Abbott-Northwestern Hospital
  - New Ulm, Minnesota, United States, 56073
    - New Ulm Medical Center
  - Robbinsdale, Minnesota, United States, 55422
    - North Memorial Medical Health Center
  - Saint Cloud, Minnesota, United States, 56303
    - Coborn Cancer Center at Saint Cloud Hospital
  - Saint Cloud, Minnesota, United States, 56303
    - Saint Cloud Hospital
  - Saint Louis Park, Minnesota, United States, 55416
    - Park Nicollet Clinic - Saint Louis Park
  - Saint Louis Park, Minnesota, United States, 55416
    - Metro Minnesota Community Oncology Research Consortium
  - Saint Paul, Minnesota, United States, 55101
    - Regions Hospital
  - Saint Paul, Minnesota, United States, 55102
    - United Hospital
  - Shakopee, Minnesota, United States, 55379
    - Saint Francis Regional Medical Center
  - Stillwater, Minnesota, United States, 55082
    - Lakeview Hospital
  - Waconia, Minnesota, United States, 55387
    - Ridgeview Medical Center
  - Willmar, Minnesota, United States, 56201
    - Rice Memorial Hospital
  - Woodbury, Minnesota, United States, 55125
    - Minnesota Oncology and Hematology PA-Woodbury
- Mississippi
  - Jackson, Mississippi, United States, 39216
    - University of Mississippi Medical Center
- Missouri
  - Cape Girardeau, Missouri, United States, 63703
    - Saint Francis Medical Center
  - Cape Girardeau, Missouri, United States, 63703
    - Southeast Cancer Center
  - Columbia, Missouri, United States, 65212
    - University of Missouri - Ellis Fischel
  - Independence, Missouri, United States, 64057
    - Centerpoint Medical Center LLC
  - Jefferson City, Missouri, United States, 65109
    - Capital Region Medical Center-Goldschmidt Cancer Center
  - Kansas City, Missouri, United States, 64128
    - Kansas City Veterans Affairs Medical Center
  - Kansas City, Missouri, United States, 64116
    - North Kansas City Hospital
  - Kansas City, Missouri, United States, 64111
    - Saint Luke's Hospital of Kansas City
  - Kansas City, Missouri, United States, 64132
    - Research Medical Center
  - Kansas City, Missouri, United States, 64118
    - Heartland Hematology and Oncology Associates Incorporated
  - Lee's Summit, Missouri, United States, 64086
    - Saint Luke's East - Lee's Summit
  - Liberty, Missouri, United States, 64068
    - Liberty Radiation Oncology Center
  - Rolla, Missouri, United States, 65401
    - Phelps County Regional Medical Center
  - Rolla, Missouri, United States, 65401
    - Saint John's Clinic-Rolla-Cancer and Hematology
  - Saint Joseph, Missouri, United States, 64506
    - Heartland Regional Medical Center
  - Saint Joseph, Missouri, United States, 64507
    - Saint Joseph Oncology Inc
  - Saint Louis, Missouri, United States, 63110
    - Washington University School of Medicine
  - Saint Louis, Missouri, United States, 63131
    - Missouri Baptist Medical Center
  - Saint Louis, Missouri, United States, 63141
    - Mercy Hospital Saint Louis
  - Saint Louis, Missouri, United States, 63109
    - Saint Louis Cancer and Breast Institute-South City
  - Springfield, Missouri, United States, 65804
    - Cancer Research for the Ozarks NCORP
  - Springfield, Missouri, United States, 65807
    - CoxHealth South Hospital
  - Springfield, Missouri, United States, 65804
    - Mercy Hospital Springfield
- Montana
  - Billings, Montana, United States, 59101
    - Saint Vincent Healthcare
  - Billings, Montana, United States, 59102
    - Frontier Cancer Center and Blood Institute-Billings
  - Billings, Montana, United States, 59107
    - Billings Clinic Cancer Center
  - Billings, Montana, United States, 59101
    - Montana Cancer Consortium NCORP
  - Bozeman, Montana, United States, 59715
    - Bozeman Deaconess Hospital
  - Butte, Montana, United States, 59701
    - Saint James Community Hospital and Cancer Treatment Center
  - Great Falls, Montana, United States, 59405
    - Benefis Healthcare- Sletten Cancer Institute
  - Great Falls, Montana, United States, 59405
    - Big Sky Oncology
  - Helena, Montana, United States, 59601
    - Saint Peter's Community Hospital
  - Kalispell, Montana, United States, 59901
    - Kalispell Regional Medical Center
  - Kalispell, Montana, United States, 59901
    - Kalispell Medical Oncology
  - Missoula, Montana, United States, 59802
    - Saint Patrick Hospital - Community Hospital
  - Missoula, Montana, United States, 59802
    - Montana Cancer Specialists
- Nebraska
  - Kearney, Nebraska, United States, 68847
    - CHI Health Good Samaritan
  - Lincoln, Nebraska, United States, 68510
    - Nebraska Cancer Research Center
  - Omaha, Nebraska, United States, 68124
    - Alegent Health Bergan Mercy Medical Center
  - Omaha, Nebraska, United States, 68122
    - Alegent Health Immanuel Medical Center
  - Omaha, Nebraska, United States, 68130
    - Alegent Health Lakeside Hospital
  - Omaha, Nebraska, United States, 68131
    - Creighton University Medical Center
  - Omaha, Nebraska, United States, 68106
    - Missouri Valley Cancer Consortium
- Nevada
  - Las Vegas, Nevada, United States, 89102
    - University Medical Center of Southern Nevada
  - Las Vegas, Nevada, United States, 89106
    - Nevada Cancer Research Foundation CCOP
- New Jersey
  - Camden, New Jersey, United States, 08103
    - Cooper Hospital University Medical Center
  - East Orange, New Jersey, United States, 07018-1095
    - Veterans Adminstration New Jersey Health Care System
  - Egg Harbor Township, New Jersey, United States, 08234
    - AtlantiCare Surgery Center
  - Englewood, New Jersey, United States, 07631
    - Englewood Hospital and Medical Center
  - Newark, New Jersey, United States, 07103
    - UMDNJ - New Jersey Medical School
- New York
  - Bronx, New York, United States, 10461
    - Albert Einstein College of Medicine
  - Bronx, New York, United States, 10467-2490
    - Montefiore Medical Center - Moses Campus
  - Brooklyn, New York, United States, 11203
    - Kings County Hospital
  - Brooklyn, New York, United States, 11203
    - State University of New York Downstate Medical Center
  - Cooperstown, New York, United States, 13326
    - Mary Imogene Bassett Hospital
  - Glens Falls, New York, United States, 12801
    - Glens Falls Hospital
  - Middletown, New York, United States, 10940
    - Orange Regional Medical Center
  - Mineola, New York, United States, 11501
    - Winthrop University Hospital
  - New York, New York, United States, 10032
    - Columbia University Medical Center
  - Rochester, New York, United States, 14642
    - University of Rochester
  - Staten Island, New York, United States, 10305
    - Staten Island University Hospital
- North Carolina
  - Asheboro, North Carolina, United States, 27203
    - Randolph Hospital
  - Goldsboro, North Carolina, United States, 27534
    - Wayne Memorial Hospital
  - Greensboro, North Carolina, United States, 27403
    - Cone Health Cancer Center
  - Kinston, North Carolina, United States, 28501
    - Kinston Medical Specialists PA
  - Pinehurst, North Carolina, United States, 28374
    - FirstHealth of the Carolinas-Moore Regional Hosiptal
  - Reidsville, North Carolina, United States, 27320
    - Annie Penn Memorial Hospital
  - Statesville, North Carolina, United States, 28677
    - Iredell Memorial Hospital
  - Winston-Salem, North Carolina, United States, 27104
    - Southeast Cancer Control Consortium CCOP
- North Dakota
  - Bismarck, North Dakota, United States, 58501
    - Sanford Bismarck Medical Center
  - Bismarck, North Dakota, United States, 58501
    - Mid Dakota Clinic
  - Bismarck, North Dakota, United States, 58501
    - Saint Alexius Medical Center
  - Fargo, North Dakota, United States, 58122
    - Sanford Clinic North-Fargo
  - Fargo, North Dakota, United States, 58122
    - Sanford Medical Center-Fargo
  - Fargo, North Dakota, United States, 58122
    - Roger Maris Cancer Center
- Ohio
  - Akron, Ohio, United States, 44304
    - Summa Akron City Hospital/Cooper Cancer Center
  - Akron, Ohio, United States, 44307
    - Akron General Medical Center
  - Barberton, Ohio, United States, 44203
    - Summa Barberton Hospital
  - Beachwood, Ohio, United States, 44122
    - Cleveland Clinic Cancer Center Beachwood
  - Belpre, Ohio, United States, 45714
    - Strecker Cancer Center-Belpre
  - Bowling Green, Ohio, United States, 43402
    - Toledo Clinic Cancer Centers-Bowling Green
  - Chillicothe, Ohio, United States, 45601
    - Adena Regional Medical Center
  - Cincinnati, Ohio, United States, 45220
    - Good Samaritan Hospital - Cincinnati
  - Cincinnati, Ohio, United States, 45242
    - Bethesda North Hospital
  - Cincinnati, Ohio, United States, 45242
    - Oncology Hematology Care Inc-Blue Ash
  - Cincinnati, Ohio, United States, 45202
    - Oncology Hematology Care Inc-Eden Park
  - Cincinnati, Ohio, United States, 45211
    - Oncology Hematology Care Inc-Mercy West
  - Cincinnati, Ohio, United States, 45230
    - Oncology Hematology Care Inc - Anderson
  - Cincinnati, Ohio, United States, 45236
    - Oncology Hematology Care Inc - Kenwood
  - Cleveland, Ohio, United States, 44106
    - Case Western Reserve University
  - Cleveland, Ohio, United States, 44109
    - MetroHealth Medical Center
  - Cleveland, Ohio, United States, 44195
    - Cleveland Clinic Foundation
  - Cleveland, Ohio, United States, 44111
    - Cleveland Clinic Cancer Center/Fairview Hospital
  - Columbus, Ohio, United States, 43214
    - Riverside Methodist Hospital
  - Columbus, Ohio, United States, 43210
    - Ohio State University Comprehensive Cancer Center
  - Columbus, Ohio, United States, 43219
    - The Mark H Zangmeister Center
  - Columbus, Ohio, United States, 43214
    - Columbus Oncology and Hematology Associates Inc
  - Columbus, Ohio, United States, 43228
    - Doctors Hospital
  - Columbus, Ohio, United States, 43215
    - Grant Medical Center
  - Columbus, Ohio, United States, 43222
    - Mount Carmel Health Center West
  - Columbus, Ohio, United States, 43215
    - Columbus CCOP
  - Dayton, Ohio, United States, 45406
    - Good Samaritan Hospital - Dayton
  - Dayton, Ohio, United States, 45409
    - Miami Valley Hospital
  - Dayton, Ohio, United States, 45415
    - Samaritan North Health Center
  - Dayton, Ohio, United States, 45405
    - Grandview Hospital
  - Dayton, Ohio, United States, 45420
    - Dayton CCOP
  - Delaware, Ohio, United States, 43015
    - Delaware Health Center-Grady Cancer Center
  - Delaware, Ohio, United States, 43015
    - Delaware Radiation Oncology
  - Delaware, Ohio, United States, 43015
    - Grady Memorial Hospital
  - Elyria, Ohio, United States, 44035
    - Mercy Cancer Center-Elyria
  - Elyria, Ohio, United States, 44035
    - Hematology Oncology Center Incorporated
  - Fairfield, Ohio, United States, 45014
    - Oncology Hematology Care Inc-Healthplex
  - Findlay, Ohio, United States, 45840
    - Blanchard Valley Hospital
  - Franklin, Ohio, United States, 45005-1066
    - Atrium Medical Center-Middletown Regional Hospital
  - Greenville, Ohio, United States, 45331
    - Wayne Hospital
  - Kettering, Ohio, United States, 45429
    - Kettering Medical Center
  - Lancaster, Ohio, United States, 43130
    - Fairfield Medical Center
  - Lancaster, Ohio, United States, 43130
    - Lancaster Radiation Oncology
  - Lima, Ohio, United States, 45801
    - Saint Rita's Medical Center
  - Lima, Ohio, United States, 45804
    - Lima Memorial Hospital
  - Marietta, Ohio, United States, 45750
    - Marietta Memorial Hospital
  - Maumee, Ohio, United States, 43537
    - Toledo Clinic Cancer Centers-Maumee
  - Maumee, Ohio, United States, 43537
    - Toledo Radiation Oncology at Northwest Ohio Onocolgy Center
  - Mayfield Heights, Ohio, United States, 44124
    - Hillcrest Hospital Cancer Center
  - Mount Vernon, Ohio, United States, 43050
    - Knox Community Hospital
  - Newark, Ohio, United States, 43055
    - Licking Memorial Hospital
  - Newark, Ohio, United States, 43055
    - Newark Radiation Oncology
  - Oregon, Ohio, United States, 43616
    - Saint Charles Hospital
  - Oregon, Ohio, United States, 43616
    - Toledo Clinic Cancer Centers-Oregon
  - Portsmouth, Ohio, United States, 45662
    - Southern Ohio Medical Center
  - Sandusky, Ohio, United States, 44870
    - North Coast Cancer Care
  - Springfield, Ohio, United States, 45505
    - Springfield Regional Medical Center
  - Strongsville, Ohio, United States, 44136
    - Cleveland Clinic Cancer Center Strongsville
  - Sylvania, Ohio, United States, 43560
    - Flower Hospital
  - Tiffin, Ohio, United States, 44883
    - Mercy Hospital of Tiffin
  - Toledo, Ohio, United States, 43608
    - Saint Vincent Mercy Medical Center
  - Toledo, Ohio, United States, 43623
    - Toledo Clinic Cancer Centers-Toledo
  - Toledo, Ohio, United States, 43614
    - University of Toledo
  - Toledo, Ohio, United States, 43617
    - Toledo Community Hospital Oncology Program CCOP
  - Toledo, Ohio, United States, 43606
    - The Toledo Hospital/Toledo Children's Hospital
  - Toledo, Ohio, United States, 43623
    - Mercy Saint Anne Hospital
  - Troy, Ohio, United States, 45373
    - Upper Valley Medical Center
  - Wauseon, Ohio, United States, 43567
    - Fulton County Health Center
  - Westerville, Ohio, United States, 43081
    - Saint Ann's Hospital
  - Wooster, Ohio, United States, 44691
    - Cleveland Clinic Wooster Specialty Center
  - Xenia, Ohio, United States, 45385
    - Greene Memorial Hospital
  - Zanesville, Ohio, United States, 43701
    - Genesis Healthcare System
- Oklahoma
  - Oklahoma City, Oklahoma, United States, 73104
    - University of Oklahoma Health Sciences Center
  - Tulsa, Oklahoma, United States, 74146
    - Tulsa Cancer Institute
  - Tulsa, Oklahoma, United States, 74136
    - Natalie Warren Bryant Cancer Center at Saint Francis
  - Tulsa, Oklahoma, United States, 74104
    - Oklahoma Oncology Inc
  - Tulsa, Oklahoma, United States, 74136
    - Warren Cancer Research Foundation
- Oregon
  - Gresham, Oregon, United States, 97030
    - Legacy Mount Hood Medical Center
  - Portland, Oregon, United States, 97210
    - Legacy Good Samaritan Hospital and Medical Center
  - Portland, Oregon, United States, 97227
    - Legacy Emanuel Hospital and Health Center
  - Tualatin, Oregon, United States, 97062
    - Legacy Meridian Park Hospital
- Pennsylvania
  - Abington, Pennsylvania, United States, 19001
    - Abington Memorial Hospital
  - Allentown, Pennsylvania, United States, 18103
    - Lehigh Valley Hospital-Cedar Crest
  - Bethlehem, Pennsylvania, United States, 18017
    - Lehigh Valley Hospital - Muhlenberg
  - Bryn Mawr, Pennsylvania, United States, 19010
    - Bryn Mawr Hospital
  - Danville, Pennsylvania, United States, 17822
    - Geisinger Medical Center
  - Hazleton, Pennsylvania, United States, 18201
    - Geisinger Medical Center-Cancer Center Hazleton
  - Lancaster, Pennsylvania, United States, 17604
    - Lancaster General Hospital
  - Lewisburg, Pennsylvania, United States, 17837
    - Geisinger Medical Oncology-Lewisburg
  - Paoli, Pennsylvania, United States, 19301
    - Paoli Memorial Hospital
  - Pittsburgh, Pennsylvania, United States, 15232
    - University of Pittsburgh Cancer Institute (UPCI)
  - Pottsville, Pennsylvania, United States, 17901
    - Geisinger Medical Oncology-Pottsville
  - Sayre, Pennsylvania, United States, 18840
    - Guthrie Medical Group PC-Robert Packer Hospital
  - State College, Pennsylvania, United States, 16801
    - Geisinger Medical Group
  - West Reading, Pennsylvania, United States, 19611
    - Reading Hospital
  - Wilkes-Barre, Pennsylvania, United States, 18711
    - Geisinger Wyoming Valley/Henry Cancer Center
  - Wynnewood, Pennsylvania, United States, 19096
    - Lankenau Medical Center
  - Wynnewood, Pennsylvania, United States, 19096
    - Mainline Health CCOP
- South Dakota
  - Sioux Falls, South Dakota, United States, 57105
    - Avera Cancer Institute
  - Sioux Falls, South Dakota, United States, 57117-5134
    - Sanford USD Medical Center - Sioux Falls
  - Sioux Falls, South Dakota, United States, 57104
    - Sanford Cancer Center-Oncology Clinic
- Tennessee
  - Chattanooga, Tennessee, United States, 37403
    - Erlanger Medical Center
  - Nashville, Tennessee, United States, 37232
    - Vanderbilt University/Ingram Cancer Center
- Texas
  - Amarillo, Texas, United States, 79106
    - The Don and Sybil Harrington Cancer Center
  - Lubbock, Texas, United States, 79430
    - Texas Tech University Health Sciences Center
- Utah
  - Salt Lake City, Utah, United States, 84112
    - Huntsman Cancer Institute/University of Utah
- Virginia
  - Danville, Virginia, United States, 24541
    - Danville Regional Medical Center
  - Danville, Virginia, United States, 24541
    - Danville Hematology Oncology
  - Fredericksburg, Virginia, United States, 22401
    - Fredericksburg Oncology Inc
  - Richmond, Virginia, United States, 23298
    - Virginia Commonwealth University/Massey Cancer Center
- Washington
  - Anacortes, Washington, United States, 98221
    - Cancer Care Center at Island Hospital
  - Bellingham, Washington, United States, 98225
    - PeaceHealth Saint Joseph Medical Center
  - Bremerton, Washington, United States, 98310
    - Harrison HealthPartners Hematology and Oncology-Bremerton
  - Burien, Washington, United States, 98166
    - Highline Medical Center-Main Campus
  - Edmonds, Washington, United States, 98026
    - Swedish Medical Center-Edmonds
  - Issaquah, Washington, United States, 98029
    - Swedish Cancer Institute-Issaquah
  - Kennewick, Washington, United States, 99336
    - Kadlec Clinic Hematology and Oncology
  - Kirkland, Washington, United States, 98034
    - Seattle Cancer Care Alliance at EvergreenHealth
  - Mount Vernon, Washington, United States, 98274
    - Skagit Valley Hospital
  - Poulsbo, Washington, United States, 98370
    - Harrison HealthPartners Hematology and Oncology-Poulsbo
  - Seattle, Washington, United States, 98109
    - Fred Hutchinson Cancer Research Center
  - Seattle, Washington, United States, 98195
    - University of Washington Medical Center
  - Seattle, Washington, United States, 98104
    - Harborview Medical Center
  - Seattle, Washington, United States, 98107
    - Swedish Medical Center-Ballard Campus
  - Seattle, Washington, United States, 98104
    - Minor and James Medical PLLC
  - Seattle, Washington, United States, 98112
    - Group Health Cooperative-Seattle
  - Seattle, Washington, United States, 98122-4307
    - Swedish Medical Center-First Hill
  - Seattle, Washington, United States, 98112
    - Group Health Cooperative of Puget Sound Oncology Consortium
  - Sedro-Woolley, Washington, United States, 98284
    - United General Hospital
  - Spokane, Washington, United States, 99218
    - Evergreen Hematology and Oncology PS
  - Spokane, Washington, United States, 99202
    - Cancer Care Northwest - Spokane South
  - Spokane, Washington, United States, 99220
    - Rockwood Clinic
  - Vancouver, Washington, United States, 98686
    - Legacy Salmon Creek Hospital
  - Wenatchee, Washington, United States, 98801
    - Wenatchee Valley Hospital and Clinics
- West Virginia
  - Charleston, West Virginia, United States, 25304
    - West Virginia University Charleston
  - Morgantown, West Virginia, United States, 26506
    - West Virginia University Healthcare
- Wisconsin
  - Antigo, Wisconsin, United States, 54409
    - Langlade Hospital and Cancer Center
  - Chippewa Falls, Wisconsin, United States, 54729
    - Marshfield Clinic-Chippewa Center
  - Eau Claire, Wisconsin, United States, 54701
    - Marshfield Clinic Cancer Center at Sacred Heart
  - Eau Claire, Wisconsin, United States, 54701
    - Sacred Heart Hospital
  - La Crosse, Wisconsin, United States, 54601
    - Gundersen Lutheran Medical Center
  - Ladysmith, Wisconsin, United States, 54848
    - Marshfield Clinic - Ladysmith Center
  - Madison, Wisconsin, United States, 53717
    - Dean Hematology and Oncology Clinic
  - Marshfield, Wisconsin, United States, 54449
    - Marshfield Clinic
  - Marshfield, Wisconsin, United States, 54449
    - Saint Joseph's Hospital
  - Minocqua, Wisconsin, United States, 54548
    - Marshfield Clinic-Minocqua Center
  - Mukwonago, Wisconsin, United States, 53149
    - D N Greenwald Center
  - New Richmond, Wisconsin, United States, 54017
    - Cancer Center of Western Wisconsin
  - Oconomowoc, Wisconsin, United States, 53066
    - Oconomowoc Memorial Hospital-ProHealth Care Inc
  - Rhinelander, Wisconsin, United States, 54501
    - Saint Mary's Hospital
  - Rhinelander, Wisconsin, United States, 54501
    - Marshfield Clinic at James Beck Cancer Center
  - Rice Lake, Wisconsin, United States, 54868
    - Marshfield Clinic-Rice Lake Center
  - Stevens Point, Wisconsin, United States, 54481
    - Saint Michael's Hospital
  - Stevens Point, Wisconsin, United States, 54481
    - Marshfield Clinic Cancer Care at Saint Michael's Hospital
  - Waukesha, Wisconsin, United States, 53188
    - Waukesha Memorial Hospital
  - Wausau, Wisconsin, United States, 54401
    - Aspirus Regional Cancer Center
  - Wausau, Wisconsin, United States, 54401
    - Marshfield Clinic-Wausau Center
  - Weston, Wisconsin, United States, 54476
    - Diagnostic and Treatment Center
  - Weston, Wisconsin, United States, 54476
    - Marshfield Clinic - Weston Center
  - Weston, Wisconsin, United States, 54476
    - Saint Clare's Hospital
  - Wisconsin Rapids, Wisconsin, United States, 54494
    - Marshfield Clinic - Wisconsin Rapids Center
- Wyoming
  - Casper, Wyoming, United States, 82609
    - Rocky Mountain Oncology
  - Sheridan, Wyoming, United States, 82801
    - Welch Cancer Center

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

Inclusion Criteria:

Patients must have histologically or cytologically confirmed diagnosis of pancreatic adenocarcinoma; patients with endocrine or neuroendocrine tumors, lymphoma of the pancreas, or ampullary cancer are not eligible
Patients must have distant metastatic disease; patients with macroscopic residual disease post-resection as the only site of disease are not eligible; patient must not have clinically significant ascites (defined as requiring paracentesis) or have brain metastases
Patients must have received one line, and no more than one line, of prior gemcitabine-based chemotherapy for advanced/metastatic pancreatic cancer and must have documentation of metastatic disease progression while on this treatment; documented disease progression must occur within 42 days of the last treatment; OR
- For patients who received one line of gemcitabine-based chemotherapy for treatment in the adjuvant setting, recurrence to a metastatic site must be documented by imaging studies within 6 months of completing chemotherapy; chemoradiation as part of adjuvant treatment is acceptable; if the patient received one line of adjuvant gemcitabine-based treatment and had disease recurrence after 6 months of completing chemotherapy, patients will only be eligible after failing one additional line of gemcitabine-based chemotherapy used to treat the metastatic disease
Patients must have measurable and/or non-measurable disease; x-rays, scans. or physical examinations for assessment of measurable disease must have been completed within 28 days prior to registration; x-rays, scans, or other tests for assessment of non-measurable disease must have been completed within 42 days prior to registration; all disease must be assessed and documented on the Baseline Tumor Assessment Form
Patients must have completed systemic therapy at least 14 days prior to registration, any surgical procedure must have been performed at least 14 days prior to registration, and radiation therapy must be completed at least 7 days prior to registration; patients must have recovered to =< grade 1 from any of the effects of prior therapies or procedures
Patients must not plan to receive concurrent chemotherapy, radiotherapy, agents known to prolong corrected QT (QTc) interval, or agents known to be strong inducers or inhibitors of cytochrome P450 3A4/5 (CYP3A4/5) or cytochrome P450 1A2 (CYP1A2)
Patient must not have received prior treatment with fluorouracil, irinotecan, leucovorin calcium, and oxaliplatin (FOLFIRINOX), FOLFOX, oxaliplatin-based chemotherapy, mitogen-activated protein kinase (MEK) inhibitors, phosphoinositide-3-kinase (PI3K) inhibitors, or protein kinase B (AKT) inhibitors
Zubrod performance status of 0-1
Leukocytes >= 3,000/mcL
Absolute neutrophil count (ANC) >= 1,500/mcL
Platelets >= 100,000/mcL
Hemoglobin >= 9.0 g/dL
Patients must have adequate kidney function as evidenced by at least ONE of the following:
- Serum creatinine =< 1.5 mg/dL within 14 days prior to registration
- Calculated creatinine clearance >= 60 mL/min; the serum creatinine value used in the calculation must have been obtained within 14 days prior to registration
Total bilirubin =< 1.5 times institutional upper limit of normal(IULN)
Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) both =< 2.5 times IULN
Patients must have an albumin level >= 3.0 g/dL within 14 days prior to registration
Patients must have an International Normalized Ratio (INR) =< 1.5 times IULN within 14 days prior to registration
Patients must have an electrocardiogram (ECG) within 14 days prior to registration; patients must have QTcF (by Fridericia's calculation) =< 450 msec (male) or =< 470 msec (female)
Patients with baseline neuropathy must be =< grade 1 according to Common Terminology Criteria for Adverse Events (CTCAE) v 4.0
Patients must not have uncontrolled diarrhea or active infection requiring antibiotics and be fully recovered from any previous serious infections within 7 days prior to registration
Patients must be able to swallow tablets and capsules
Patients with diabetes must be well controlled with fasting glucose =< grade 1 according to CTCAE v 4.0 within 14 days prior to registration
Patients with history of congestive heart failure must have an ejection fraction >= 55% within 14 days prior to registration
Patients must not have any of the following: uncontrolled hypertension, acute coronary syndrome within 6 months prior to registration, poorly controlled angina, New York Heart Association class II-IV heart failure, prior or current cardiomyopathy, atrial fibrillation, or severe valvular heart disease
Patients must not have a current or past history of central serous retinopathy, retinal vein occlusion, retinal detachment, or have uncontrolled glaucoma (irrespective of intraocular pressure [IOP])
No prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease-free for five years
Patients must not be pregnant or nursing; women/men of reproductive potential must have agreed to use an effective contraceptive method during the study plus at least 16 weeks after last dose; a woman is considered to be of "reproductive potential" if she has had menses at any time in the preceding 12 consecutive months; in addition to routine contraceptive methods, "effective contraception" also includes heterosexual celibacy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) defined as a hysterectomy, bilateral oophorectomy or bilateral tubal ligation; however, if at any point a previously celibate patient chooses to become heterosexually active during the time period for use of contraceptive measures outlined in the protocol, he/she is responsible for beginning contraceptive measures
Prestudy history and physical must be obtained within 28 days prior to registration
Sites must seek additional patient consent for the future use of specimens
All patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines
As part of the Oncology Patient Enrollment Network (OPEN) registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered into the system

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 Assignment
Masking: None (Open Label)

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm I (mFOLFOX regimen) Patients receive oxaliplatin IV over 2 hours on days 1 and 15 and fluorouracil IV over 46-48 hours on days 1-2 and 15-16.	Drug: Fluorouracil Given IV Other Names: 5-FU 5-Fluracil Fluracil 5-Fluoro-2,4(1H, 3H)-pyrimidinedione 5-Fluorouracil AccuSite Fluoro Uracil Fluouracil Flurablastin Fluracedyl Fluril Fluroblastin Ribofluor Ro 2-9757 Ro-2-9757 Adrucil Efudex Actino-Hermal Arumel Cytosafe Efurix Fiverocil Fluoroplex Flurox Timazin Drug: Oxaliplatin Given IV Other Names: 1-OHP Dacotin Dacplat Eloxatin Diaminocyclohexane Oxalatoplatinum Eloxatine JM-83 Oxalatoplatin Oxalatoplatinum RP 54780 RP-54780 SR-96669
Experimental: Arm II (Akt inhibitor MK2206 and selumetinib) Patients receive Akt inhibitor MK2206 PO on days 1, 8, 15, and 22, and selumetinib PO daily on days 1-28.	Drug: Akt Inhibitor MK2206 Given PO Other Names: MK2206 Drug: Selumetinib Given PO Other Names: AZD6244 ARRY-142886 MEK Inhibitor AZD6244

Participant Group / Arm

Intervention / Treatment

Experimental: Arm I (mFOLFOX regimen)

Patients receive oxaliplatin IV over 2 hours on days 1 and 15 and fluorouracil IV over 46-48 hours on days 1-2 and 15-16.

Drug: Fluorouracil

Given IV

Other Names:

5-FU
5-Fluracil
Fluracil
5-Fluoro-2,4(1H, 3H)-pyrimidinedione
5-Fluorouracil
AccuSite
Fluoro Uracil
Fluouracil
Flurablastin
Fluracedyl
Fluril
Fluroblastin
Ribofluor
Ro 2-9757
Ro-2-9757
Adrucil
Efudex
Actino-Hermal
Arumel
Cytosafe
Efurix
Fiverocil
Fluoroplex
Flurox
Timazin

Drug: Oxaliplatin

Given IV

Other Names:

1-OHP
Dacotin
Dacplat
Eloxatin
Diaminocyclohexane Oxalatoplatinum
Eloxatine
JM-83
Oxalatoplatin
Oxalatoplatinum
RP 54780
RP-54780
SR-96669

Experimental: Arm II (Akt inhibitor MK2206 and selumetinib)

Patients receive Akt inhibitor MK2206 PO on days 1, 8, 15, and 22, and selumetinib PO daily on days 1-28.

Drug: Akt Inhibitor MK2206

Given PO

Other Names:

MK2206

Drug: Selumetinib

Given PO

Other Names:

AZD6244
ARRY-142886
MEK Inhibitor AZD6244

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival Time Frame: Up to 3 years	From date of registration to date of death due to any cause. Patients last known to be alive are censored at date of last contact.	Up to 3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug Time Frame: Up to 3 years	Only adverse events that are possibly, probably or definitely related to study drug are reported.	Up to 3 years

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-free Survival Time Frame: Up to 3 years	From date of registration to date of first documentation of progression or symptomatic deterioration, or death due to any cause. Patients last known to be alive and progression free are censored at date of last contact.	Up to 3 years
Objective Response Rate Time Frame: Up to 3 years	Confirmed response (CR) is two or more objective statuses of CR a minimum of four weeks apart documented before progression or symptomatic deterioration. Partial response (PR) is two or more objective statuses of PR or better a minimum of four weeks apart documented before progression or symptomatic deterioration. Unconfirmed CR is one objective status of CR documented before progression or symptomatic deterioration but not qualifying as CR or PR. Unconfirmed PR is one objective status of PR documented before progression or symptomatic deterioration but not qualifying as CR, PR or unconfirmed CR.	Up to 3 years

Collaborators and Investigators

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

Sponsor

National Cancer Institute (NCI)

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

Chung V, McDonough S, Philip PA, Cardin D, Wang-Gillam A, Hui L, Tejani MA, Seery TE, Dy IA, Al Baghdadi T, Hendifar AE, Doyle LA, Lowy AM, Guthrie KA, Blanke CD, Hochster HS. Effect of Selumetinib and MK-2206 vs Oxaliplatin and Fluorouracil in Patients With Metastatic Pancreatic Cancer After Prior Therapy: SWOG S1115 Study Randomized Clinical Trial. JAMA Oncol. 2017 Apr 1;3(4):516-522. doi: 10.1001/jamaoncol.2016.5383.

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

August 1, 2012

Primary Completion (Actual)

June 1, 2015

Study Completion (Actual)

June 1, 2015

Study Registration Dates

First Submitted

August 3, 2012

First Submitted That Met QC Criteria

August 3, 2012

First Posted (Estimate)

August 7, 2012

Study Record Updates

Last Update Posted (Estimate)

March 9, 2016

Last Update Submitted That Met QC Criteria

February 10, 2016

Last Verified

July 1, 2015

More Information

Terms related to this study

Other Study ID Numbers

NCI-2012-01993 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
U10CA032102 (U.S. NIH Grant/Contract)
U10CA180888 (U.S. NIH Grant/Contract)
SWOG-S1115
CDR0000737878
S1115 (Other Identifier: CTEP)

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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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

Other Outcome Measures

Outcome Measure

Measure Description

Time Frame

Collaborators and Investigators

Sponsor

Publications and helpful links

General Publications

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 (Estimate)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Clinical Trials on Pancreatic Ductal Adenocarcinoma

Clinical Trials on Akt Inhibitor MK2206

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Conditions

Rare Diseases

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Sponsor/Collaborators

Locations