A Phase I Study of Imatinib (Gleevec) in Combination With Irinotecan and Cisplatin in Extensive Stage Small Cell Lung Cancer
- Determine the maximum tolerated dose of imatinib mesylate when administered with
irinotecan and cisplatin in patients with extensive stage small cell lung cancer.
- Determine the effect of imatinib mesylate on irinotecan metabolism by the cytochrome
p450 system in these patients.
- Determine the response rate, time to progression, and survival of patients treated with
OUTLINE: This is a dose-escalation study of imatinib mesylate.
Patients receive irinotecan IV over 30 minutes on days 1, 8, and 15 and cisplatin IV over 60
minutes on day 1. Treatment repeats every 28 days for 4 courses in the absence of disease
progression or unacceptable toxicity. Patients also receive oral imatinib mesylate once or
twice daily beginning on day 22 of course 1 and continuing until disease progression or
Cohorts of 3-6 patients receive escalating doses of imatinib mesylate until the maximum
tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which
at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
PROJECTED ACCRUAL: Approximately 18 patients will be accrued for this study within 12-18
Primary Purpose: Treatment
Lee M. Krug, MD
Memorial Sloan-Kettering Cancer Center
United States: Federal Government
|Memorial Sloan-Kettering Cancer Center||New York, New York 10021|