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
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.
Primary Purpose: Treatment
Leonard B. Saltz, MD
Memorial Sloan-Kettering Cancer Center
United States: Federal Government
|Memorial Sloan-Kettering Cancer Center||New York, New York 10021|