Colorectal Cancer Clinical Trial
Official title:
Phase II Study of an Anti-Epidermal Growth Factor Receptor (EGFR) Antibody, Cetuximab, in Patients With Irinotecan-Refractory, Stage IV Colorectal Carcinoma
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.
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.
;
Primary Purpose: Treatment
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