A Phase II Trial of Preoperative Irinotecan (CPT-11) in Patients With High-Risk Resectable Metastatic Colorectal Cancer
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Colorectal Cancer
- Sponsor
- Memorial Sloan Kettering Cancer Center
- Locations
- 1
- Status
- Completed
- Last Updated
- 12 years ago
Overview
Brief Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of irinotecan in treating patients with metastatic colorectal cancer.
Detailed Description
OBJECTIVES: I. Evaluate the clinical usefulness of preoperative irinotecan in patients with high risk, technically resectable metastatic colorectal cancer that is refractory to fluorouracil. II. Evaluate prospectively the relationship between expression of selected molecular determinants of response and clinical responsiveness to irinotecan in these patients. III. Determine the effect of treatment with irinotecan on the expression of putative response determinants in these patients. OUTLINE: This is an open label study. Patients receive irinotecan IV over 90 minutes weekly for 4 consecutive weeks. Course repeats every 6 weeks. After 2 courses, CT scan is obtained and patients showing evidence of disease that is still amenable to surgical resection undergo surgery. Approximately 4-8 weeks after surgical resection, patients receive 3 additional courses of irinotecan in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 2 years and then every 6 months for years 3 and 4. PROJECTED ACCRUAL: A total of 30 patients will be accrued into this study.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Not specified