Cetuximab 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.
PURPOSE: Phase II trial to study the effectiveness of cetuximab in treating patients who have stage IV colorectal cancer that has not responded to previous treatment.
|Study Design:||Primary Purpose: Treatment|
|Official Title:||Phase II Study of an Anti-Epidermal Growth Factor Receptor (EGFR) Antibody, Cetuximab, in Patients With Irinotecan-Refractory, Stage IV Colorectal Carcinoma|
|Study Start Date:||March 2001|
|Primary Completion Date:||August 2002 (Final data collection date for primary outcome measure)|
OBJECTIVES: I. Determine the response rate of patients with irinotecan-refractory, stage IV colorectal cancer when treated with cetuximab. II. Determine the safety and toxic effects of this drug in these patients. III. Determine the time to progression of patients treated with this drug.
OUTLINE: This is a multicenter study. Patients receive cetuximab IV over 1-2 hours weekly for 6 weeks. Treatment repeats in the absence of disease progression or unacceptable toxicity. Patients are followed at 4 weeks and then every 3 months thereafter.
PROJECTED ACCRUAL: A total of 20-40 patients will be accrued for this study within 4 months.
|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|