Ignite Creation Date:
2024-05-05 @ 11:57 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00194935
Status:
TERMINATED
Last Update Posted:
2006-09-13
First Post:
2005-09-13
Brief Title:
Weekly Topotecan Therapy in Patients With Ovarian Cancer
Sponsor:
Weill Medical College of Cornell University
Organization:
Weill Medical College of Cornell University
Study Overview
Official Title:
A Phase II Trial of Weekly Topotecan As Consolidation Therapy in Ovarian Cancer Patients After Initial Chemotherapy
Status:
TERMINATED
Status Verified Date:
2006-09
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:
The purpose of this study is to find out the safety and feasibility of weekly topotecan consolidation therapy in patients with ovarian cancer
Detailed Description:
Patients with Stage IIIC and IV optimally-debulked ovarian cancer will be treated with 6 cycles every 3 weeks of carboplatin AUC 5 and paclitaxel 175 mgm2 Patients who demonstrate a complete clinical response to this regimen will then be treated with topotecan consolidation 4 mgm2 weekly x 8 weeks for one cycle followed by a break in the 9th week for a maximum of 3 cycles Primary endpoints will be toxicity and the determination of the appropriate dose schedule and duration of topotecan for further consolidation trials
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