Ignite Creation Date:
2024-05-05 @ 9:36 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006454
Status:
COMPLETED
Last Update Posted:
2015-12-23
First Post:
2000-11-06
Brief Title:
Paclitaxel Plus Carboplatin With or Without Topotecan in Treating Patients With Stage IIB Stage III or Stage IV Ovarian Epithelial 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:
2015-12
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:
RATIONALE Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die Combining more than one drug may kill more tumor cells It is not yet known if paclitaxel plus carboplatin is more effective with or without topotecan for ovarian epithelial cancer
PURPOSE Randomized phase III trial to compare the effectiveness of paclitaxel plus carboplatin with or without topotecan in treating patients who have stage IIB stage III or stage IV ovarian epithelial cancer
PURPOSE Randomized phase III trial to compare the effectiveness of paclitaxel plus carboplatin with or without topotecan in treating patients who have stage IIB stage III or stage IV ovarian epithelial cancer
Detailed Description:
OBJECTIVES I Compare survival of patients with stage IIB III or IV ovarian epithelial carcinoma after receiving treatment with paclitaxel and carboplatin with or without topotecan II Compare progression-free survival of these patients after receiving these treatment regimens III Compare the response rate and response duration in these patients treated with these regimens IV Determine the toxic effects of the combination of paclitaxel carboplatin and topotecan in these patients V Compare the toxic effects of these treatment regimens in these patients VI Compare quality of life of these patients treated with these regimens
OUTLINE This is a randomized multicenter study Patients are stratified according to participating center and stage stage IIB and stage III optimally debulked to no greater than 1 cm residual tumor vs stage IV regardless of residual tumor or residual tumor greater than 1 cm Patients are randomized to one of two treatment arms Arm I Patients receive paclitaxel IV over 3 hours and carboplatin IV over 05-1 hour on day 1 and topotecan IV over 05 hour on days 1-5 Treatment repeats every 21 days for 6 courses topotecan is administered for 4 courses only Arm II Patients receive paclitaxel and carboplatin as in arm I Treatment repeats every 21 days for 6 courses Quality of life is assessed before courses 1 3 and 5 and at 3 weeks and 3 months after completion of treatment in both treatment arms before courses 1 and 3 of topotecan in arm I and at 6 months after completion of treatment in arm II Patients are followed every 3 months for 2 years every 6 months for 3 years and then annually thereafter
PROJECTED ACCRUAL A total of 914 patients 457 per treatment arm will be accrued for this study over 2 years
OUTLINE This is a randomized multicenter study Patients are stratified according to participating center and stage stage IIB and stage III optimally debulked to no greater than 1 cm residual tumor vs stage IV regardless of residual tumor or residual tumor greater than 1 cm Patients are randomized to one of two treatment arms Arm I Patients receive paclitaxel IV over 3 hours and carboplatin IV over 05-1 hour on day 1 and topotecan IV over 05 hour on days 1-5 Treatment repeats every 21 days for 6 courses topotecan is administered for 4 courses only Arm II Patients receive paclitaxel and carboplatin as in arm I Treatment repeats every 21 days for 6 courses Quality of life is assessed before courses 1 3 and 5 and at 3 weeks and 3 months after completion of treatment in both treatment arms before courses 1 and 3 of topotecan in arm I and at 6 months after completion of treatment in arm II Patients are followed every 3 months for 2 years every 6 months for 3 years and then annually thereafter
PROJECTED ACCRUAL A total of 914 patients 457 per treatment arm will be accrued for this study over 2 years
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 |
|---|---|---|---|
| NCI-V00-1602 | None | None | None |
| AGOSG-OVAR-7 | None | None | None |