A Phase I Study Of STI 571 (Gleevec) In Combination With Cisplatin/Irinotecan In Patients With Extensive Stage Small Cell Lung Cancer
- Determine the maximum tolerated dose of imatinib mesylate when administered with
cisplatin and irinotecan in patients with extensive stage small cell lung cancer.
- Determine the recommended phase II dose of imatinib mesylate in patients treated with
- Determine the response rate, median duration of response, progression-free survival,
median survival, and overall survival of patients treated with this regimen.
OUTLINE: This is a multicenter, dose-escalation study of imatinib mesylate.
Patients receive cisplatin IV over 1 hour on day 1 and irinotecan IV over 60 minutes on days
1, 8, and 15. Treatment repeats every 28 days for a maximum of 4 courses. Patients also
receive oral imatinib mesylate daily continually for one week prior to, during, and after
chemotherapy in the absence of disease progression or unacceptable toxicity.
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 at which 2 of 3 or 2 of 6
patients experience dose-limiting toxicity. Once the MTD is determined, additional patients
are treated at the recommended phase II dose (one dose level below the MTD).
PROJECTED ACCRUAL: A total of 12-24 patients will be accrued for this study within 1-2
Primary Purpose: Treatment
Mark D. Vincent, MD
London Regional Cancer Program at London Health Sciences Centre
United States: Federal Government