Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004186
Status:
COMPLETED
Last Update Posted:
2013-04-12
First Post:
2000-01-21
Brief Title:
Combination Chemotherapy in Treating Patients With Small Cell Lung Cancer
Sponsor:
University of Alabama at Birmingham
Organization:
University of Alabama at Birmingham
Study Overview
Official Title:
Phase IIIA Study of Sequential Ifosfamide and Topotecan in Patients With 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 Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die Combining more than one drug may kill more tumor cells
PURPOSE Phase III trial to study the effectiveness of combination chemotherapy in treating patients who have small cell lung cancer
PURPOSE Phase III trial to study the effectiveness of combination chemotherapy in treating patients who have small cell lung cancer
Detailed Description:
OBJECTIVES I Determine the maximum tolerated dose and dose limiting toxicity of topotecan when combined with ifosfamide in patients with limited or extensive stage small cell lung cancer II Determine the pharmacokinetics of topotecan and correlate with toxicity or tumor response in these patients III Determine the effect of topotecan on apoptosis in tumor tissues and correlate the apoptosis-inducing effects with antitumor effects of topotecan in these patients IV Determine the response rate time to progression and survival of chemotherapy naive limited or extensive stage small cell lung cancer patients treated with ifosfamide and topotecan and then crossover consolidationsalvage therapy with carboplatin and etoposide V Determine the response rate time to progression and survival of pretreated limited or extensive stage small cell lung cancer patients treated with ifosfamide and topotecan as salvage therapy
OUTLINE This is a dose escalation study of topotecan phase I Patients are stratified by disease stage extensive vs limited and prior chemotherapy naive vs pretreated in phase II Induction therapy Patients receive topotecan IV over 72 hours and ifosfamide IV over 30 minutes every 3 weeks Chemotherapy naive patients with complete or partial response after 3 courses stable disease after 2 courses or progressive disease at any time receive consolidationsalvage chemotherapy Pretreated patients continue on induction regimen for a minimum of 6 courses unless disease progression or unacceptable toxicity Phase I Cohorts of 3-6 patients receive escalating doses of topotecan until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 3 of 6 patients experience dose limiting toxicity Salvage chemotherapy Patients with extensive stage disease receive carboplatin IV over 30 minutes on day 1 and etoposide IV over 45 minutes on days 1 2 and 3 Treatment repeats every 3 weeks for up to 4 to 6 courses Patients with limited stage disease undergoing chest irradiation receive treatment every 28 days for the first course Patients are followed every 2 months for 1 year every 3 months for 1 year and then every 4 months thereafter
PROJECTED ACCRUAL Approximately 15-20 patients will be accrued for phase I and approximately 35 patients will be accrued for phase II of this study
OUTLINE This is a dose escalation study of topotecan phase I Patients are stratified by disease stage extensive vs limited and prior chemotherapy naive vs pretreated in phase II Induction therapy Patients receive topotecan IV over 72 hours and ifosfamide IV over 30 minutes every 3 weeks Chemotherapy naive patients with complete or partial response after 3 courses stable disease after 2 courses or progressive disease at any time receive consolidationsalvage chemotherapy Pretreated patients continue on induction regimen for a minimum of 6 courses unless disease progression or unacceptable toxicity Phase I Cohorts of 3-6 patients receive escalating doses of topotecan until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 3 of 6 patients experience dose limiting toxicity Salvage chemotherapy Patients with extensive stage disease receive carboplatin IV over 30 minutes on day 1 and etoposide IV over 45 minutes on days 1 2 and 3 Treatment repeats every 3 weeks for up to 4 to 6 courses Patients with limited stage disease undergoing chest irradiation receive treatment every 28 days for the first course Patients are followed every 2 months for 1 year every 3 months for 1 year and then every 4 months thereafter
PROJECTED ACCRUAL Approximately 15-20 patients will be accrued for phase I and approximately 35 patients will be accrued for phase II of 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 |
|---|---|---|---|
| NCI-G99-1647 | None | None | None |
| UAB-9626 | None | None | None |
| UAB-F961125015 | None | None | None |