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Sponsors and Collaborators: |
Cancer and Leukemia Group B National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00077233 |
RATIONALE: Drugs used in chemotherapy, such as fluorouracil, leucovorin, irinotecan, and oxaliplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies such as cetuximab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Combining more than one drug with a monoclonal antibody may kill more tumor cells. It is not yet known which combination chemotherapy regimen is more effective with or without cetuximab in treating metastatic adenocarcinoma (cancer) of the colon or rectum.
PURPOSE: Randomized phase III trial to compare the effectiveness of combining fluorouracil and leucovorin with either irinotecan or oxaliplatin with or without cetuximab in treating patients who have metastatic cancer of the colon or rectum.
Condition | Intervention | Phase |
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Colorectal Cancer |
Biological: cetuximab Drug: FOLFIRI regimen Drug: FOLFOX regimen Drug: fluorouracil Drug: irinotecan hydrochloride Drug: leucovorin calcium Drug: oxaliplatin |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control |
Official Title: | A Phase III Trial Of Irinotecan /5-FU/ Leucovorin Or Oxaliplatin /5-FU / Leucovorin With And Without Cetuximab (C225) For Patients With Untreated Metastatic Adenocarcinoma Of The Colon or Rectum |
Study Start Date: | January 2004 |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to prior adjuvant therapy (yes vs no) and prior pelvic radiotherapy (yes vs no). Patients are randomized to 1 of 4 treatment arms.
In all arms, courses repeat every 8 weeks in the absence of disease progression or unacceptable toxicity.
Patients are followed every 2 months for 2 years and then every 3 months for 3 years.
PROJECTED ACCRUAL: Approximately 2,200 patients (550 per treatment arm) will be accrued for this study within 4.6 years.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed metastatic colorectal adenocarcinoma
Histologic or cytologic confirmation is not required for recurrent metastatic disease in patients with prior colorectal cancer treated with surgery unless either of the following criteria are met:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Pulmonary
Neurologic
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
No concurrent hormonal therapy except the following:
Radiotherapy
Surgery
Other
United States, Alabama | |
Northeast Alabama Regional Medical Center | |
Anniston, Alabama, United States, 36207 | |
United States, California | |
Cedars-Sinai Comprehensive Cancer Center at Cedars-Sinai Medical Center | |
Los Angeles, California, United States, 90048 | |
Naval Medical Center - San Diego | |
San Diego, California, United States, 92134-3202 | |
Rebecca and John Moores UCSD Cancer Center | |
La Jolla, California, United States, 92093-0658 | |
UCSF Comprehensive Cancer Center | |
San Francisco, California, United States, 94115 | |
Veterans Affairs Medical Center - San Diego | |
San Diego, California, United States, 92161 | |
Veterans Affairs Medical Center - San Francisco | |
San Francisco, California, United States, 94121 | |
United States, Delaware | |
CCOP - Christiana Care Health Services | |
Newark, Delaware, United States, 19713 | |
United States, District of Columbia | |
Lombardi Cancer Center at Georgetown University Medical Center | |
Washington, District of Columbia, United States, 20007 | |
Veterans Affairs Medical Center - Washington, DC | |
Washington, District of Columbia, United States, 20422 | |
Walter Reed Army Medical Center | |
Washington, District of Columbia, United States, 20307-5001 | |
United States, Florida | |
Broward General Medical Center | |
Fort Lauderdale, Florida, United States, 33316 | |
CCOP - Mount Sinai Medical Center | |
Miami Beach, Florida, United States, 33140 | |
Florida Hospital Cancer Institute | |
Orlando, Florida, United States, 32804 | |
Memorial Regional Cancer Center at Memorial Regional Hospital | |
Hollywood, Florida, United States, 33021 | |
Palm Beach Cancer Institute | |
West Palm Beach, Florida, United States, 33401 | |
United States, Illinois | |
CCOP - Evanston | |
Evanston, Illinois, United States, 60201 | |
CCOP - Illinois Oncology Research Association | |
Peoria, Illinois, United States, 61615-7828 | |
Louis A. Weiss Memorial Hospital | |
Chicago, Illinois, United States, 60640 | |
MBCCOP - University of Illinois at Chicago | |
Chicago, Illinois, United States, 60612 | |
University of Chicago Cancer Research Center | |
Chicago, Illinois, United States, 60637-1470 | |
Veterans Affairs Medical Center - Chicago (Westside Hospital) | |
Chicago, Illinois, United States, 60612 | |
West Suburban Center for Cancer Care | |
River Forest, Illinois, United States, 60305 | |
United States, Indiana | |
CCOP - Northern Indiana CR Consortium | |
South Bend, Indiana, United States, 46601 | |
Fort Wayne Medical Oncology and Hematology, Incorporated | |
Fort Wayne, Indiana, United States, 46885-5099 | |
United States, Iowa | |
Holden Comprehensive Cancer Center at University of Iowa | |
Iowa City, Iowa, United States, 52242-1009 | |
United States, Kentucky | |
Baptist Hospital East - Louisville | |
Louisville, Kentucky, United States, 40207 | |
United States, Maryland | |
Greenebaum Cancer Center at University of Maryland Medical Center | |
Baltimore, Maryland, United States, 21201 | |
United States, Massachusetts | |
Beth Israel Deaconess Medical Center | |
Boston, Massachusetts, United States, 02215 | |
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute | |
Boston, Massachusetts, United States, 02115 | |
UMASS Memorial Cancer Center - University Campus | |
Worcester, Massachusetts, United States, 01655 | |
United States, Michigan | |
Lakeland Cancer Care Center at Lakeland Hospital - St. Joseph | |
Saint Joseph, Michigan, United States, 49085 | |
United States, Minnesota | |
University of Minnesota Cancer Center | |
Minneapolis, Minnesota, United States, 55455 | |
Veterans Affairs Medical Center - Minneapolis | |
Minneapolis, Minnesota, United States, 55417 | |
United States, Missouri | |
Siteman Cancer Center at Barnes-Jewish Hospital | |
Saint Louis, Missouri, United States, 63110 | |
Ellis Fischel Cancer Center at University of Missouri - Columbia | |
Columbia, Missouri, United States, 65203 | |
Missouri Baptist Cancer Center | |
Saint Louis, Missouri, United States, 63131 | |
CCOP - Kansas City | |
Kansas City, Missouri, United States, 64131 | |
Veterans Affairs Medical Center - Columbia (Truman Memorial) | |
Columbia, Missouri, United States, 65201 | |
United States, Nebraska | |
UNMC Eppley Cancer Center at the University of Nebraska Medical Center | |
Omaha, Nebraska, United States, 68198-7680 | |
United States, Nevada | |
CCOP - Southern Nevada Cancer Research Foundation | |
Las Vegas, Nevada, United States, 89106 | |
Veterans Affairs Medical Center - Las Vegas | |
Las Vegas, Nevada, United States, 89106 | |
United States, New Hampshire | |
New Hampshire Oncology-Hematology, PA - Hooksett | |
Hooksett, New Hampshire, United States, 03106 | |
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center | |
Lebanon, New Hampshire, United States, 03756-0002 | |
United States, New Jersey | |
Cooper University Hospital | |
Camden, New Jersey, United States, 08103 | |
United States, New York | |
CCOP - North Shore University Hospital | |
Manhasset, New York, United States, 11030 | |
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C. | |
East Syracuse, New York, United States, 13057 | |
Memorial Sloan-Kettering Cancer Center | |
New York, New York, United States, 10021 | |
Mount Sinai Medical Center | |
New York, New York, United States, 10029 | |
New York Weill Cornell Cancer Center at Cornell University | |
New York, New York, United States, 10021 | |
North Shore University Hospital | |
Manhasset, New York, United States, 11030 | |
Queens Cancer Center of Queens Hospital | |
Jamaica, New York, United States, 11432 | |
SUNY Upstate Medical University Hospital | |
Syracuse, New York, United States, 13210 | |
Veterans Affairs Medical Center - Buffalo | |
Buffalo, New York, United States, 14215 | |
Veterans Affairs Medical Center - Syracuse | |
Syracuse, New York, United States, 13210 | |
United States, North Carolina | |
Cape Fear Valley Health System | |
Fayetteville, North Carolina, United States, 28302-2000 | |
CCOP - Southeast Cancer Control Consortium | |
Goldsboro, North Carolina, United States, 27534-9479 | |
Comprehensive Cancer Center at Wake Forest University | |
Winston-Salem, North Carolina, United States, 27157-1082 | |
Duke Comprehensive Cancer Center | |
Durham, North Carolina, United States, 27710 | |
FirstHealth Moore Regional Hospital | |
Pinehurst, North Carolina, United States, 28374 | |
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill | |
Chapel Hill, North Carolina, United States, 27599-7295 | |
NorthEast Oncology Associates - Concord | |
Concord, North Carolina, United States, 28025 | |
Veterans Affairs Medical Center - Asheville | |
Asheville, North Carolina, United States, 28805 | |
Veterans Affairs Medical Center - Durham | |
Durham, North Carolina, United States, 27705 | |
Zimmer Cancer Center at New Hanover Regional Medical Center | |
Wilmington, North Carolina, United States, 28402-9025 | |
United States, Ohio | |
Arthur G. James Cancer Hospital at Ohio State University | |
Columbus, Ohio, United States, 43210-1240 | |
United States, Oklahoma | |
Oklahoma University Medical Center | |
Oklahoma City, Oklahoma, United States, 73104 | |
United States, Pennsylvania | |
Western Pennsylvania Hospital | |
Pittsburgh, Pennsylvania, United States, 15224 | |
United States, Rhode Island | |
Lifespan: The Miriam Hospital | |
Providence, Rhode Island, United States, 02906 | |
United States, Texas | |
Simmons Cancer Center at University of Texas Southwestern Medical Center - Dallas | |
Dallas, Texas, United States, 75390-8852 | |
Veterans Affairs Medical Center - Dallas | |
Dallas, Texas, United States, 75219 | |
United States, Vermont | |
Vermont Cancer Center at University of Vermont | |
Burlington, Vermont, United States, 05401-3498 | |
United States, Virginia | |
Martha Jefferson Hospital | |
Charlottesville, Virginia, United States, 22902 | |
MBCCOP - Massey Cancer Center | |
Richmond, Virginia, United States, 23298-0037 | |
Oncology and Hematology Associates of Southwest Virginia, Incorporated - Roanoke | |
Roanoke, Virginia, United States, 24014 | |
Virginia Oncology Associates - Norfolk | |
Norfolk, Virginia, United States, 23502 | |
United States, West Virginia | |
St. Mary's Medical Center | |
Huntington, West Virginia, United States, 25701 |
Study Chair: | Alan P. Venook, MD | UCSF Helen Diller Family Comprehensive Cancer Center |
Investigator: | Charles S. Fuchs, MD | Dana-Farber Cancer Institute |
Study ID Numbers: | CDR0000350016, CALGB-80203 |
Study First Received: | February 10, 2004 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00077233 History of Changes |
Health Authority: | United States: Federal Government |
adenocarcinoma of the colon adenocarcinoma of the rectum recurrent colon cancer |
recurrent rectal cancer stage IV colon cancer stage IV rectal cancer |
Antimetabolites Immunologic Factors Gastrointestinal Diseases Rectal Neoplasms Colonic Diseases Irinotecan Leucovorin Rectal Diseases Oxaliplatin Vitamins Micronutrients Vitamin B Complex Digestive System Neoplasms Cetuximab Rectal Neoplasm |
Trace Elements Folinic Acid Intestinal Diseases Immunosuppressive Agents Intestinal Neoplasms Recurrence Camptothecin Carcinoma Calcium, Dietary Digestive System Diseases Rectal Cancer Fluorouracil Gastrointestinal Neoplasms Adenocarcinoma Antineoplastic Agents, Phytogenic |
Antimetabolites Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Gastrointestinal Diseases Physiological Effects of Drugs Colonic Diseases Irinotecan Leucovorin Rectal Diseases Oxaliplatin Neoplasms by Site Vitamins Therapeutic Uses |
Micronutrients Vitamin B Complex Digestive System Neoplasms Neoplasms by Histologic Type Growth Substances Cetuximab Enzyme Inhibitors Intestinal Diseases Immunosuppressive Agents Pharmacologic Actions Intestinal Neoplasms Camptothecin Carcinoma Neoplasms Digestive System Diseases |