Ignite Creation Date:
2024-05-05 @ 11:28 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00045604
Status:
COMPLETED
Last Update Posted:
2008-07-24
First Post:
2002-09-06
Brief Title:
Imatinib Mesylate and Chemotherapy in Treating Patients With Extensive-Stage Small Cell Lung Cancer
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase I Study of Imatinib Gleevec in Combination With Irinotecan and Cisplatin in Extensive Stage Small Cell Lung Cancer
Status:
COMPLETED
Status Verified Date:
2004-04
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 the enzymes necessary for tumor cell growth Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die Combining imatinib mesylate with chemotherapy may kill more tumor cells
PURPOSE Phase I trial to study the effectiveness of combining imatinib mesylate with irinotecan and cisplatin in treating patients who have extensive-stage small cell lung cancer
PURPOSE Phase I trial to study the effectiveness of combining imatinib mesylate with irinotecan and cisplatin in treating patients who have extensive-stage small cell lung cancer
Detailed Description:
OBJECTIVES
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 this regimen
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 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 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 months
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 this regimen
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 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 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 months
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-5653 | None | None | None |
| MSKCC-02015 | None | None | None |