Gleevec Maintenance Therapy After Induction Irinotecan and Cisplatin in Patients With C-Kit Positive Extensive SCLC
This study involves being treated initially with a combination of drugs called irinotecan and cisplatin (induction therapy), followed by treatment with a drug called Gleevec (maintenance therapy). The main purpose of this study is to determine if this type of treatment will delay the growth of the tumor and if so, for how long. The investigators also want to find out how the tumor is affected solely by induction therapy with irinotecan and cisplatin, what side-effects occur when Gleevec maintenance therapy is used, and if this treatment (induction followed by maintenance therapy) will improve the duration of survival
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Trial of Gleevec (Imatinib Mesylate, STI571) Maintenance Therapy After Induction Irinotecan and Cisplatin in Patients With C-Kit Positive, Extensive-Stage Small Cell Lung Cancer|
- Tumor assessment should have been done within 28 days of starting Gleevec. Tumor assessment will be done every 8 weeks while on Gleevec.
- Clinical assessment, labs, and toxicity will be done weekly from weeks 2 through 8. Evaluation may be done more frequently after the first 8 weeks if required, but should be done at least every 4 weeks.
|Study Start Date:||March 2002|
|Study Completion Date:||April 2006|
|Primary Completion Date:||January 2006 (Final data collection date for primary outcome measure)|
|United States, Michigan|
|Univeristy of Michigan Cancer Center|
|Ann Arbor, Michigan, United States, 48109|
|Principal Investigator:||Gregory Kalemkerian, M.D.||University of Michigan Cancer Center|