Ignite Creation Date:
2024-05-05 @ 4:43 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00305942
Status:
COMPLETED
Last Update Posted:
2013-01-31
First Post:
2006-03-20
Brief Title:
Topotecan and Carboplatin in the First-Line Treatment of Patients With Extensive Stage Small Cell Lung Cancer
Sponsor:
SCRI Development Innovations LLC
Organization:
SCRI Development Innovations LLC
Study Overview
Official Title:
A Phase II Trial of Topotecan and Carboplatin in the First-Line Treatment of Patients With Extensive Stage Small Cell Lung Cancer
Status:
COMPLETED
Status Verified Date:
2013-01
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:
This proposed phase II trial will investigate the combination of topotecancarboplatin in the first-line treatment of patients with extensive-stage SCLC Topotecanplatinum regimens are emerging as common treatments for patients with extensive-stage disease This trial will be one of the first clinical trials to evaluate a combination of weekly topotecan and carboplatin in the first-line treatment of extensive-stage SCLC
Detailed Description:
Eligible patients will receive treatment with carboplatin and topotecan
Topotecan 4mgm2 IV on days 1 8
Carboplatin AUC5 IV day 1 only
- Cycles are repeated every 21 days for 4 cycles of topotecan and carboplatin maximum 6 courses Restaging studies will be performed every 2 cycles or 6 weeks
Topotecan 4mgm2 IV on days 1 8
Carboplatin AUC5 IV day 1 only
- Cycles are repeated every 21 days for 4 cycles of topotecan and carboplatin maximum 6 courses Restaging studies will be performed every 2 cycles or 6 weeks
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