Combination Chemotherapy and Monoclonal Antibody Therapy in Treating Patients With Metastatic Colorectal Cancer
Recruitment status was Active, not recruiting
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies such as ABX-EGF can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Combining chemotherapy with monoclonal antibody therapy may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combining irinotecan, leucovorin, and fluorouracil with ABX-EGF in treating patients who have metastatic colorectal cancer.
Drug: irinotecan hydrochloride
Drug: leucovorin calcium
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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|
|Study Start Date:||July 2002|
- Determine progression-free survival of patients with metastatic colorectal cancer treated with monoclonal antibody ABX-EGF, irinotecan, leucovorin calcium, and fluorouracil.
- 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 unacceptable toxicity.
Patients are followed within 4 weeks, every 3 months for 1 year, and then every 6 months for 1 year.
PROJECTED ACCRUAL: A total of 84 patients will be accrued for this study.
|United States, California|
|Jonsson Comprehensive Cancer Center, UCLA|
|Los Angeles, California, United States, 90095-7187|
|Principal Investigator:||Joel Randolph Hecht, MD||Jonsson Comprehensive Cancer Center|