Ignite Creation Date:
2024-05-05 @ 11:19 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003644
Status:
COMPLETED
Last Update Posted:
2019-06-04
First Post:
1999-11-01
Brief Title:
Carboplatin Plus Paclitaxel With or Without Continued Low-Dose Paclitaxel in Treating Patients With Early-Stage Ovarian Cancer
Sponsor:
Gynecologic Oncology Group
Organization:
GOG Foundation
Study Overview
Official Title:
A Randomized Phase III Trial of IV Carboplatin AUC 6 and Paclitaxel 175 mgm2 Q 21 Days x 3 Courses Plus Low Dose Paclitaxel 40 mgm2wk Versus IV Carboplatin AUC 6 and Paclitaxel 175 mgm2 Q 21 Days x 3 Courses Plus Observation in Patients With Early Stage Ovarian Carcinoma
Status:
COMPLETED
Status Verified Date:
2016-03
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:
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 whether receiving combined carboplatin and paclitaxel plus continued low-dose paclitaxel is more effective than carboplatin and paclitaxel alone for early-stage ovarian cancer
PURPOSE This randomized phase III trial is studying carboplatin and paclitaxel alone too see how well they work compared to carboplatin and paclitaxel together with continued low-dose paclitaxel in treating patients with early-stage ovarian cancer
PURPOSE This randomized phase III trial is studying carboplatin and paclitaxel alone too see how well they work compared to carboplatin and paclitaxel together with continued low-dose paclitaxel in treating patients with early-stage ovarian cancer
Detailed Description:
OBJECTIVES
Compare the progression-free interval and overall survival of patients with early stage ovarian epithelial cancer treated with carboplatin and paclitaxel with or without low-dose paclitaxel
Assess the frequency and severity of toxic effects of these regimens in these patients
OUTLINE This is a randomized multicenter study Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive paclitaxel IV over 3 hours followed by carboplatin IV over 30 minutes Treatment repeats every 21 days for 3 courses Four weeks after the completion of paclitaxel and carboplatin patients receive low-dose paclitaxel IV over 1 hour once a week for 24 weeks
Arm II Patients receive paclitaxel IV over 3 hours followed by carboplatin IV over 30 minutes Treatment repeats every 21 days for 3 courses Patients then undergo observation
Patients are followed every 3 months for 2 years every 6 months for 3 years and then annually thereafter
PROJECTED ACCRUAL A total of 500 patients will be accrued for this study within 55 years
Compare the progression-free interval and overall survival of patients with early stage ovarian epithelial cancer treated with carboplatin and paclitaxel with or without low-dose paclitaxel
Assess the frequency and severity of toxic effects of these regimens in these patients
OUTLINE This is a randomized multicenter study Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive paclitaxel IV over 3 hours followed by carboplatin IV over 30 minutes Treatment repeats every 21 days for 3 courses Four weeks after the completion of paclitaxel and carboplatin patients receive low-dose paclitaxel IV over 1 hour once a week for 24 weeks
Arm II Patients receive paclitaxel IV over 3 hours followed by carboplatin IV over 30 minutes Treatment repeats every 21 days for 3 courses Patients then undergo observation
Patients are followed every 3 months for 2 years every 6 months for 3 years and then annually thereafter
PROJECTED ACCRUAL A total of 500 patients will be accrued for this study within 55 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 |
|---|---|---|---|
| SWOG-G0175 | None | None | None |
| NCI-2012-02291 | None | None | None |