Phase II Trial of Imatinib Mesylate Maintenance Therapy in Patients With C-Kit (+) Extensive-Stage Small Cell Lung Cancer
- Determine the 4-month progression-free survival rate in patients with c-kit positive,
extensive stage small cell lung cancer treated with maintenance therapy comprising
imatinib mesylate after induction therapy comprising irinotecan and cisplatin.
- Determine the overall survival of patients treated with this regimen.
- Determine the tolerability of imatinib mesylate maintenance therapy in these patients.
- Determine the response rate in patients treated with irinotecan and cisplatin.
OUTLINE: This is a multicenter study.
- Induction therapy: Patients receive irinotecan IV over 90 minutes on days 1 and 8 and
cisplatin IV on day 1. Treatment repeats every 21 days for 4 courses in the absence of
disease progression or unacceptable toxicity. Patients achieving a response (partial or
complete) or stable disease proceed to maintenance therapy.
- Maintenance therapy: Patients receive oral imatinib mesylate twice daily for 6 months
in the absence of disease progression or unacceptable toxicity. Some patients may
continue to receive therapy for up to 1 year.
After completion of study treatment, patients are followed for 4 months.
PROJECTED ACCRUAL: A total of 80 patients will be accrued for this study.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
at 4 months
Shirish M. Gadgeel, MD
Barbara Ann Karmanos Cancer Institute
United States: Federal Government
|University of Michigan Comprehensive Cancer Center||Ann Arbor, Michigan 48109-0752|
|Barbara Ann Karmanos Cancer Institute||Detroit, Michigan 48201|