A Clinical Trial of the Safety and Efficacy of ABX-EGF in Combination With Irinotecan, Leucovorin, and 5-Fluorouracil in Patients With Metastatic Colorectal Cancer
- Determine progression-free survival of patients with metastatic colorectal cancer
treated with monoclonal antibody ABX-EGF, irinotecan, leucovorin calcium, and
- Determine additional measures of clinical efficacy of this regimen in these patients.
- Determine the safety of this regimen in these patients.
- Determine the pharmacokinetics of monoclonal antibody ABX-EGF when administered with
this regimen in these patients.
- Determine the pharmacokinetics of irinotecan and its active metabolite SN-38 when
administered with this regimen in these patients.
OUTLINE: This is a multicenter study.
Patients receive monoclonal antibody ABX-EGF IV over 1 hour, irinotecan IV over 90 minutes,
leucovorin calcium IV, and fluorouracil IV over 5 minutes on days 1, 8, 15, and 22.
Treatment repeats every 6 weeks for up to 8 courses in the absence of disease progression or
Patients are followed within 4 weeks, every 3 months for 1 year, and then every 6 months for
PROJECTED ACCRUAL: A total of 84 patients will be accrued for this study.
Masking: Open Label, Primary Purpose: Treatment
Joel Randolph Hecht, MD
Jonsson Comprehensive Cancer Center
United States: Federal Government
|Jonsson Comprehensive Cancer Center, UCLA||Los Angeles, California 90095-1781|