Colorectal Cancer Clinical Trial
Official title:
An Open Label Phase II Clinical Trial To Evaluate The Safety And Efficacy Of ABX-EGF In Patients With Metastatic Colorectal Carcinoma
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.
OBJECTIVES:
- 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.
;
Primary Purpose: Treatment
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