Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006374
Status:
WITHDRAWN
Last Update Posted:
2014-01-15
First Post:
2000-10-04
Brief Title:
Combination Chemotherapy in Treating Patients With Extensive-Stage Small Cell Lung Cancer
Sponsor:
Case Comprehensive Cancer Center
Organization:
Case Comprehensive Cancer Center
Study Overview
Official Title:
An Open-Label Multicenter Randomized Phase II Study of TopotecanPaclitaxel vs EtoposideCisplatin as First-Line Therapy for Patients With Extensive Disease Small Cell Lung Cancer
Status:
WITHDRAWN
Status Verified Date:
2014-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Slow accrual
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 It is not yet known which combination chemotherapy regimen is more effective for treating extensive-stage small cell lung cancer
PURPOSE Randomized phase II trial to compare the effectiveness of combining topotecan and paclitaxel with that of combining etoposide and cisplatin in treating patients who have extensive-stage small cell lung cancer
PURPOSE Randomized phase II trial to compare the effectiveness of combining topotecan and paclitaxel with that of combining etoposide and cisplatin in treating patients who have extensive-stage small cell lung cancer
Detailed Description:
OBJECTIVES I Compare the response rates in patients with extensive stage small cell lung cancer treated with topotecan and paclitaxel versus etoposide and cisplatin II Compare time to response response duration time to progression and survival in these patients treated with these regimens III Determine the toxicity profiles of these regimens in these patients IV Compare the effects of these regimens on symptoms of disease in these patients
OUTLINE This is a randomized open label multicenter study Patients are stratified according to gender ECOG performance status 0-1 vs 2 and elevated LDH absent vs present Patients are randomized to one of two treatment arms Arm I Patients receive paclitaxel IV over 3 hours on day 1 and topotecan IV over 30 minutes on days 1-5 Patients also receive filgrastim G-CSF subcutaneously beginning on day 6 and continuing until blood counts recover Arm II Patients receive cisplatin IV over 3 hours on day 1 and etoposide IV over 30 minutes on days 1-3 Treatment continues every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity Patients are followed every 3 months
PROJECTED ACCRUAL A total of 150 patients 75 per treatment arm will be accrued for this study
OUTLINE This is a randomized open label multicenter study Patients are stratified according to gender ECOG performance status 0-1 vs 2 and elevated LDH absent vs present Patients are randomized to one of two treatment arms Arm I Patients receive paclitaxel IV over 3 hours on day 1 and topotecan IV over 30 minutes on days 1-5 Patients also receive filgrastim G-CSF subcutaneously beginning on day 6 and continuing until blood counts recover Arm II Patients receive cisplatin IV over 3 hours on day 1 and etoposide IV over 30 minutes on days 1-3 Treatment continues every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity Patients are followed every 3 months
PROJECTED ACCRUAL A total of 150 patients 75 per treatment arm 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 |
|---|---|---|---|
| NCI-G00-1864 | None | None | None |
| CWRU-SKF-2598 | None | None | None |
| CWRU-059916 | None | None | None |
| SB-SKF-104864RSD-1010P34 | None | None | None |