Ignite Creation Date:
2024-05-05 @ 11:30 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00061308
Status:
COMPLETED
Last Update Posted:
2017-06-09
First Post:
2003-05-23
Brief Title:
Second-line Intravenous Treatment For Recurrent Platinum-Sensitive Ovarian Fallopian Or Peritoneal Cancer
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
An Open-label Multicenter Non-Comparative Phase II Study of the Combination of Intravenous Topotecan and Gemcitabine Administered Once Weekly for Three Weeks Every 28 Days as Second-line Treatment in Patients With Recurrent Platinum Sensitive Ovarian Cancer
Status:
COMPLETED
Status Verified Date:
2013-03
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 research study was designed to determine the effectiveness of the drug topotecan given intravenously into a vein together with the drug gemcitabine in patients with recurrent platinum-sensitive ovarian fallopian or primary peritoneal cancer as well as tumors of mixed mullerian origin Additional purposes are to determine the long term outcome and side effects of this combination treatment
Since topotecan and gemcitabine have different mechanisms of action the combination of these 2 drugs may provide better results than either drug alone Prior studies suggest that the combination of topotecan and gemcitabine improves the effects on the tumor and also appeared to be well tolerated
Since topotecan and gemcitabine have different mechanisms of action the combination of these 2 drugs may provide better results than either drug alone Prior studies suggest that the combination of topotecan and gemcitabine improves the effects on the tumor and also appeared to be well tolerated
Detailed Description:
None
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