Ignite Creation Date:
2024-05-05 @ 11:40 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00102375
Status:
COMPLETED
Last Update Posted:
2006-08-04
First Post:
2005-01-29
Brief Title:
Paclitaxel Carboplatin and Topotecan in Patients With Ovarian Cancer
Sponsor:
AGO Study Group
Organization:
AGO Study Group
Study Overview
Official Title:
Phase III Multicenter Study in Epithelial Ovarian Carcinoma FIGO Stage IIB-IV Comparing Treatment With Paclitaxel and Carboplatin to Paclitaxel and Carboplatin Sequentially Followed by Topotecan
Status:
COMPLETED
Status Verified Date:
2006-02
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 determine whether the triple combination of Carboplatin Paclitaxel and Topotecan has a superior clinical outcome in the treatment of ovarian cancer compared with the combination of Carboplatin and Paclitaxel
Detailed Description:
Carboplatin-Paclitaxel is the current standard in the first-line treatment of advanced ovarian cancer One option to further improve the therapeutic results is the incorporation of a third non-cross-resistant drug into first line chemotherapy of advanced ovarian cancer In two separate single center phase II studies a different combination of the three active agents Carboplatin Paclitaxel and Topotecan has been tested In these studies Carboplatin and Paclitaxel were given at standard doses and schedules followed sequentially by Topotecan which was well tolerated at a dose of 125 mgm2day given for five days and repeated every 21 days The prolonged therapy is not associated with cumulative toxicity and the compliance of the patients was good
Study HypothesisComparison The triple combination CarboplatinPaclitaxelTopotecan yields superior outcome in the treatment of first-line ovarian cancer compared with the combination of Carboplatin Paclitaxel
Study HypothesisComparison The triple combination CarboplatinPaclitaxelTopotecan yields superior outcome in the treatment of first-line ovarian cancer compared with the combination of Carboplatin Paclitaxel
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