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Sponsors and Collaborators: |
North Central Cancer Treatment Group National Cancer Institute (NCI) Cancer and Leukemia Group B National Cancer Institute of Canada Eastern Cooperative Oncology Group Southwest Oncology Group |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00003594 |
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.
Condition | Intervention | Phase |
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Colorectal Cancer |
Drug: FOLFOX regimen Drug: fluorouracil Drug: leucovorin calcium Drug: oxaliplatin |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Active Control |
Official Title: | 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 |
Study Start Date: | October 1998 |
OBJECTIVES:
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.
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.)
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
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:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Study Chair: | Henry C. Pitot, MD | Mayo Clinic |
Investigator: | Roscoe F. Morton, MD, FACP | John Stoddard Cancer Center at Iowa Methodist Medical Center |
Study Chair: | Charles S. Fuchs, MD | Dana-Farber Cancer Institute |
Study Chair: | Brian P. Findlay, MD | St. Catharines General Hospital at Niagara Health System |
Study Chair: | Ramesh K. Ramanathan, MD | UPMC Cancer Centers |
Study Chair: | Stephen K. Williamson, MD | University of Kansas |
Study ID Numbers: | CDR0000066665, NCCTG-N9741, CAN-NCIC-CO13, CLB-89804, E-N9741, SWOG-N9741 |
Study First Received: | November 1, 1999 |
Last Updated: | January 10, 2009 |
ClinicalTrials.gov Identifier: | NCT00003594 |
Health Authority: | United States: Federal Government |
stage III colon cancer stage IV colon cancer stage III rectal cancer stage IV rectal cancer |
recurrent colon cancer recurrent rectal cancer adenocarcinoma of the colon adenocarcinoma of the rectum |
Digestive System Neoplasms Rectal Neoplasms Gastrointestinal Diseases Irinotecan Colonic Diseases Leucovorin Intestinal Diseases Rectal Diseases Recurrence Intestinal Neoplasms Rectal neoplasm |
Carcinoma Calcium, Dietary Oxaliplatin Digestive System Diseases Fluorouracil Gastrointestinal Neoplasms Adenocarcinoma Rectal cancer Colorectal Neoplasms Neoplasms, Glandular and Epithelial |
Antimetabolites Neoplasms by Histologic Type Antimetabolites, Antineoplastic Vitamin B Complex Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Growth Substances |
Physiological Effects of Drugs Immunosuppressive Agents Pharmacologic Actions Neoplasms Neoplasms by Site Vitamins Therapeutic Uses Micronutrients |