Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00052494
Status:
COMPLETED
Last Update Posted:
2015-07-23
First Post:
2003-01-24
Brief Title:
Combination Chemotherapy and Imatinib Mesylate in Treating Patients With Extensive-Stage Small Cell Lung Cancer
Sponsor:
University Health Network Toronto
Organization:
University Health Network Toronto
Study Overview
Official Title:
A Phase I Study Of STI 571 Gleevec In Combination With CisplatinIrinotecan In Patients With Extensive Stage Small Cell Lung Cancer
Status:
COMPLETED
Status Verified Date:
2015-07
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 Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die Imatinib mesylate may stop the growth of tumor cells by blocking the enzymes necessary for their growth Combining more than one chemotherapy drug with imatinib mesylate may kill more tumor cells
PURPOSE Phase I trial to study the effectiveness of combining cisplatin irinotecan and imatinib mesylate in treating patients who have extensive-stage small cell lung cancer
PURPOSE Phase I trial to study the effectiveness of combining cisplatin irinotecan and imatinib mesylate 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 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 this regimen
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 years
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 this regimen
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 years
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 |
|---|---|---|---|
| NCI-5684 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000258487 | REGISTRY | None | None |