Monoclonal Antibody Therapy in Treating Patients With Metastatic Colorectal Cancer
RATIONALE: Monoclonal antibodies 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 monoclonal antibody therapy in treating patients who have relapsed or refractory metastatic colorectal cancer.
|Study Design:||Primary Purpose: Treatment|
|Official Title:||An Open Label Phase II Clinical Trial To Evaluate The Safety And Efficacy Of ABX-EGF In Patients With Metastatic Colorectal Carcinoma|
|Study Start Date:||July 2002|
|Primary Completion Date:||May 2003 (Final data collection date for primary outcome measure)|
- Determine the response rate of patients with metastatic colorectal cancer treated with monoclonal antibody ABX-EGF.
- Determine the additional measures of clinical efficacy of this drug, in terms of progression-free survival, overall survival, and time to treatment failure, in these patients.
- Determine the safety of this drug in these patients.
OUTLINE: This is a multicenter study.
Patients receive monoclonal antibody ABX-EGF IV over 1 hour weekly on weeks 1-8. Treatment repeats every 8 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed at 4 weeks, every 3 months for 1 year, and then every 6 months for 1 year.
PROJECTED ACCRUAL: A total of 20-100 patients will be accrued for this study.
|United States, California|
|Jonsson Comprehensive Cancer Center, UCLA|
|Los Angeles, California, United States, 90095-1781|
|Principal Investigator:||Joel Randolph Hecht, MD||Jonsson Comprehensive Cancer Center|