Phase II Study of an Anti-Epidermal Growth Factor Receptor (EGFR) Antibody, Cetuximab, in Patients With Irinotecan-Refractory, Stage IV Colorectal Carcinoma
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.
Interventional
Primary Purpose: Treatment
Leonard B. Saltz, MD
Study Chair
Memorial Sloan-Kettering Cancer Center
United States: Federal Government
CDR0000068731
NCT00020930
March 2001
Name | Location |
---|---|
Memorial Sloan-Kettering Cancer Center | New York, New York 10021 |