Ignite Creation Date:
2024-05-05 @ 12:06 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00248482
Status:
COMPLETED
Last Update Posted:
2013-04-29
First Post:
2005-11-03
Brief Title:
Imatinib Mesylate After Irinotecan and Cisplatin in Treating Patients With Extensive-Stage Small Cell Lung Cancer
Sponsor:
Barbara Ann Karmanos Cancer Institute
Organization:
Barbara Ann Karmanos Cancer Institute
Study Overview
Official Title:
Phase II Trial of Imatinib Mesylate Maintenance Therapy in Patients With C-Kit Extensive-Stage Small Cell Lung Cancer
Status:
COMPLETED
Status Verified Date:
2013-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Imatinib mesylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth Drugs used in chemotherapy such as irinotecan and cisplatin work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing Giving more than one drug combination chemotherapy may kill more tumor cells Giving imatinib mesylate after irinotecan and cisplatin may keep the tumor from coming back
PURPOSE This phase II trial is studying how well giving imatinib mesylate after irinotecan and cisplatin works in treating patients with extensive-stage small cell lung cancer
PURPOSE This phase II trial is studying how well giving imatinib mesylate after irinotecan and cisplatin works in treating patients with extensive-stage small cell lung cancer
Detailed Description:
OBJECTIVES
Primary
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
Secondary
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
Primary
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
Secondary
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| P30CA022453 | NIH | None | None |
| WSU-C-2461 | OTHER | None | None |
| WSU-UMCC-2001-066 | None | None | None |
| CST1571B US93 | OTHER | Novartis Pharmaceuticals | httpsreporternihgovquickSearchP30CA022453 |