Ignite Creation Date:
2024-05-05 @ 11:38 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00090610
Status:
COMPLETED
Last Update Posted:
2015-02-25
First Post:
2004-08-27
Brief Title:
Second-Line Treatment for Patients With Platinum-Sensitive Ovarian Cancer
Sponsor:
Duke University
Organization:
Duke University
Study Overview
Official Title:
Multicenter Randomized Phase II Comparative Study to Compare Efficacy Safety of TaxotereCarboplatin Combination Therapy vs Sequential Therapy w Taxotere Then Carboplatin as Second-line Treatment of Patients w Relapsed Platinum-sensitive Ovarian Cancer
Status:
COMPLETED
Status Verified Date:
2012-12
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 compare the progression-free survival of two treatment regimens for relapsed ovarian cancer
Detailed Description:
Primary Objective
The primary objective of the study is to compare the progression-free survival of two treatment regimens
Taxotere 30 mgm2 IV on Days 1 and 8 combined with carboplatin AUC 6 IV on Day 1 repeated every 21 days for 6 cycles or until disease progression A patient who has completed 6 cycles of treatment and who has achieved a partial response or stable disease may either continue or stop treatment at the investigators discretion
Versus
Taxotere 30 mgm2 IV on Days 1 and 8 repeated every 21 days up to 6 cycles or until disease progression Followed by carboplatin AUC 6 IV every 21 days if the patient does not achieve a complete response or has disease progression on Taxotere A patient who has achieved a complete response on Taxotere will be followed until the subsequent recurrence at which time she will then receive single-agent carboplatin Carboplatin treatment will be discontinued if the patient has completed 6 cycles of treatment and has achieved a complete response or has disease progression A patient who has completed 6 cycles of carboplatin treatment and who has achieved a partial response or stable disease may either continue or stop treatment at the investigators discretion
Secondary Objectives
The secondary objectives of the study are to compare the objective response rates defined as a complete response plus partial response duration of tumor response median survival QOL and safety in patients treated with the two regimens described above
The primary objective of the study is to compare the progression-free survival of two treatment regimens
Taxotere 30 mgm2 IV on Days 1 and 8 combined with carboplatin AUC 6 IV on Day 1 repeated every 21 days for 6 cycles or until disease progression A patient who has completed 6 cycles of treatment and who has achieved a partial response or stable disease may either continue or stop treatment at the investigators discretion
Versus
Taxotere 30 mgm2 IV on Days 1 and 8 repeated every 21 days up to 6 cycles or until disease progression Followed by carboplatin AUC 6 IV every 21 days if the patient does not achieve a complete response or has disease progression on Taxotere A patient who has achieved a complete response on Taxotere will be followed until the subsequent recurrence at which time she will then receive single-agent carboplatin Carboplatin treatment will be discontinued if the patient has completed 6 cycles of treatment and has achieved a complete response or has disease progression A patient who has completed 6 cycles of carboplatin treatment and who has achieved a partial response or stable disease may either continue or stop treatment at the investigators discretion
Secondary Objectives
The secondary objectives of the study are to compare the objective response rates defined as a complete response plus partial response duration of tumor response median survival QOL and safety in patients treated with the two regimens described above
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 |
|---|---|---|---|
| DUMC03 | Other Identifier | Duke UMC | None |
| DUKE UNIVERSITY MEDICAL CENTER | OTHER | None | None |