Cetuximab Plus Combination Chemotherapy in Treating Patients With Stage IV Colorectal Cancer
RATIONALE: Monoclonal antibodies such as cetuximab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining monoclonal antibody therapy with combination chemotherapy may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combining cetuximab with combination chemotherapy in treating patients who have stage IV colorectal cancer.
|Colorectal Cancer||Biological: cetuximab Drug: fluorouracil Drug: irinotecan hydrochloride Drug: leucovorin calcium||Phase 2|
|Study Design:||Primary Purpose: Treatment|
|Official Title:||Pilot Study of an Anti-Epidermal Growth Factor Receptor (EGFR) Antibody, Cetuximab, in Combination With Irinotecan, Fluorouracil, and Leucovorin, and in Patients With Newly Diagnosed Stage IV Colorectal Carcinoma|
|Study Start Date:||February 2001|
|Study Completion Date:||February 2004|
|Primary Completion Date:||February 2004 (Final data collection date for primary outcome measure)|
OBJECTIVES: I. Determine the safety profile of cetuximab, irinotecan, leucovorin calcium, and fluorouracil in patients with stage IV colorectal cancer. II. Determine the response rate and time to progression in patients treated with this regimen.
OUTLINE: This is a multicenter study. Patients receive cetuximab IV over 1-2 hours once weekly on weeks 1-6. Patients also receive irinotecan IV over 90 minutes, leucovorin calcium IV over 10-15 minutes, and fluorouracil IV over 3-5 minutes once weekly on weeks 1-4. Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity. Patients are followed at 1 month and then every 3 months thereafter.
PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study within 2 months.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00020917
|United States, New York|
|Memorial Sloan-Kettering Cancer Center|
|New York, New York, United States, 10021|
|Study Chair:||Leonard B. Saltz, MD||Memorial Sloan Kettering Cancer Center|