A Phase II Trial of Preoperative Irinotecan (CPT-11) in Patients With High-Risk Resectable Metastatic Colorectal Cancer
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.
Primary Purpose: Treatment
Leonard B. Saltz, MD
Memorial Sloan-Kettering Cancer Center
United States: Federal Government
|Memorial Sloan-Kettering Cancer Center||New York, New York 10021|