Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00011986
Status:
COMPLETED
Last Update Posted:
2019-04-16
First Post:
2001-03-03
Brief Title:
Combination Chemotherapy in Treating Patients With Stage III or Stage IV Ovarian Epithelial Cancer or Primary Peritoneal Cancer
Sponsor:
Gynecologic Oncology Group
Organization:
GOG Foundation
Study Overview
Official Title:
A Phase III Randomized Trial Of Paclitaxel And Carboplatin Versus Triplet Or Sequential Doublet Combinations In Patients With Epithelial Ovarian Or Primary Peritoneal 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:
Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die It is not yet known which combination chemotherapy regimen is most effective in treating ovarian epithelial cancer and peritoneal cancer Randomized phase III trial to compare the effectiveness of various combination chemotherapy regimens in treating patients who have stage III or stage IV ovarian cancer or primary peritoneal cancer
Detailed Description:
OBJECTIVES
Compare the efficacy of paclitaxel and carboplatin with or without gemcitabine doxorubicin HCl liposome or topotecan in terms of overall and progression-free survival in patients with stage III or IV ovarian epithelial or serous primary peritoneal carcinoma
Determine the response rate in patients with measurable disease treated with these regimens
Compare the toxic effects of these regimens in these patients Compare the complications in patients treated with these regimens Determine the dose-intensity and cumulative dose delivery for these regimens in these patients
OUTLINE
This is a randomized multicenter study Patients are stratified into 1 of 3 strata according to extent of residual disease and plans for interval cytoreductive surgery Stratum A Optimal microscopic or macroscopic residual disease without plans for surgery Stratum B Suboptimal residual disease without plans for surgery Stratum C Suboptimal residual disease with plans for surgeryPatients are randomized to 1 of 5 treatment arms Arm I Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1 Treatment continues every 3 weeks for 8 courses in the absence of disease progression or unacceptable toxicity Arm II Patients receive chemotherapy as in arm I and gemcitabine IV over 30 minutes on days 1 and 8 Treatment continues as in arm I Arm III Patients receive chemotherapy as in arm I during courses 1-8 and doxorubicin HCl liposome IV over 1 hour on day 1 during courses 1 3 5 and 7 Treatment continues as in arm I Arm IV Patients receive topotecan IV over 30 minutes on days 1-3 and carboplatin IV over 30 minutes on day 3 Treatment continues every 3 weeks for 4 courses Patients then receive 4 courses of arm I chemotherapy Arm V Patients receive gemcitabine IV over 30 minutes on days 1 and 8 and carboplatin IV over 30 minutes on day 8 Treatment continues every 3 weeks for 4 courses Patients then receive 4 courses of arm I chemotherapy Patients with initial unresectable or suboptimal residual disease more than 1 cm may undergo interval cytoreductive surgery between courses 4 and 5 of chemotherapy Patients are followed every 3 months for 2 years and then every 6 months
PROJECTED ACCRUAL Approximately 4000-5000 patients 800-1000 per treatment arm will be accrued for this study within 35-5 years
Compare the efficacy of paclitaxel and carboplatin with or without gemcitabine doxorubicin HCl liposome or topotecan in terms of overall and progression-free survival in patients with stage III or IV ovarian epithelial or serous primary peritoneal carcinoma
Determine the response rate in patients with measurable disease treated with these regimens
Compare the toxic effects of these regimens in these patients Compare the complications in patients treated with these regimens Determine the dose-intensity and cumulative dose delivery for these regimens in these patients
OUTLINE
This is a randomized multicenter study Patients are stratified into 1 of 3 strata according to extent of residual disease and plans for interval cytoreductive surgery Stratum A Optimal microscopic or macroscopic residual disease without plans for surgery Stratum B Suboptimal residual disease without plans for surgery Stratum C Suboptimal residual disease with plans for surgeryPatients are randomized to 1 of 5 treatment arms Arm I Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1 Treatment continues every 3 weeks for 8 courses in the absence of disease progression or unacceptable toxicity Arm II Patients receive chemotherapy as in arm I and gemcitabine IV over 30 minutes on days 1 and 8 Treatment continues as in arm I Arm III Patients receive chemotherapy as in arm I during courses 1-8 and doxorubicin HCl liposome IV over 1 hour on day 1 during courses 1 3 5 and 7 Treatment continues as in arm I Arm IV Patients receive topotecan IV over 30 minutes on days 1-3 and carboplatin IV over 30 minutes on day 3 Treatment continues every 3 weeks for 4 courses Patients then receive 4 courses of arm I chemotherapy Arm V Patients receive gemcitabine IV over 30 minutes on days 1 and 8 and carboplatin IV over 30 minutes on day 8 Treatment continues every 3 weeks for 4 courses Patients then receive 4 courses of arm I chemotherapy Patients with initial unresectable or suboptimal residual disease more than 1 cm may undergo interval cytoreductive surgery between courses 4 and 5 of chemotherapy Patients are followed every 3 months for 2 years and then every 6 months
PROJECTED ACCRUAL Approximately 4000-5000 patients 800-1000 per treatment arm will be accrued for this study within 35-5 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-2012-02376 | REGISTRY | None | None |
| SWOG-G0182 | None | None | None |
| CDR0000068467 | None | None | None |
| ISRCTN41636183 | None | None | None |
| MRC-ICON5 | None | None | None |
| ECOG-G0182 | None | None | None |
| GOG-0182 | OTHER | None | None |
| GOG-0182 | OTHER | None | None |
| U10CA027469 | NIH | CTEP | httpsreporternihgovquickSearchU10CA027469 |