Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002819
Status:
TERMINATED
Last Update Posted:
2013-04-11
First Post:
1999-11-01
Brief Title:
Chemotherapy With or Without Peripheral Stem Cell Transplantation in Treating Patients With Persistent Ovarian Epithelial Cancer
Sponsor:
Gynecologic Oncology Group
Organization:
GOG Foundation
Study Overview
Official Title:
A RANDOMIZED CONTROLLED TRIAL OF SALVAGE THERAPY WITH PACLITAXEL AND CARBOPLATIN VERSU SALVAGE THERAPY WITH STEM CELL SUPPORTED HIGH-DOSE CARBOPLATIN MITOXANTRONE AND CYCLOPHOSPHAMIDE IN PATIENTS WITH PERSISTENT LOW VOLUME OVARIAN CANCER AND RESPONSE TO PRIMARY THERAPY
Status:
TERMINATED
Status Verified Date:
2007-05
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 Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy or radiation therapy used to kill tumor cells It is not yet known whether chemotherapy alone is more effective than chemotherapy plus peripheral stem cell transplantation for ovarian epithelial cancer
PURPOSE Randomized phase III trial to compare the effectiveness of paclitaxel and carboplatin with that of carboplatin mitoxantrone and cyclophosphamide followed by peripheral stem cell transplantation in treating patients who have persistent stage III or stage IV ovarian epithelial cancer
PURPOSE Randomized phase III trial to compare the effectiveness of paclitaxel and carboplatin with that of carboplatin mitoxantrone and cyclophosphamide followed by peripheral stem cell transplantation in treating patients who have persistent stage III or stage IV ovarian epithelial cancer
Detailed Description:
OBJECTIVES I Compare progression-free and overall survival of patients with drug-sensitive low-volume ovarian cancer that is persistent following standard therapy treated with salvage therapy comprising standard-dose paclitaxel and carboplatin vs high-dose carboplatin mitoxantrone and cyclophosphamide followed by bone marrow reconstitution II Compare the toxic effects of these two salvage regimens III Compare selected health-related aspects of quality of life in these patients
OUTLINE This is a randomized multicenter study Patients are stratified by participating center and disease state at reassessment laparotomy Patients are randomized to one of two treatment arms Arm I Patients receive paclitaxel IV over 3 hours on day 1 and carboplatin IV continuously on days 1-5 every 3 weeks for a total of 6 courses Arm II Patients receive cyclophosphamide IV over 1 hour and mitoxantrone IV over 15 minutes on days -8 -6 and -4 and carboplatin IV continuously on days -8 through -4 followed by rescue with autologous bone marrow or peripheral blood stem cells on day 0 Quality of life is assessed at baseline at 3 and 9 weeks after starting treatment and every 3 months for an additional 5 assessments regardless of disease progression
PROJECTED ACCRUAL A total of 275 patients will be accrued over approximately 60 months
OUTLINE This is a randomized multicenter study Patients are stratified by participating center and disease state at reassessment laparotomy Patients are randomized to one of two treatment arms Arm I Patients receive paclitaxel IV over 3 hours on day 1 and carboplatin IV continuously on days 1-5 every 3 weeks for a total of 6 courses Arm II Patients receive cyclophosphamide IV over 1 hour and mitoxantrone IV over 15 minutes on days -8 -6 and -4 and carboplatin IV continuously on days -8 through -4 followed by rescue with autologous bone marrow or peripheral blood stem cells on day 0 Quality of life is assessed at baseline at 3 and 9 weeks after starting treatment and every 3 months for an additional 5 assessments regardless of disease progression
PROJECTED ACCRUAL A total of 275 patients will be accrued over approximately 60 months
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-G0164 | None | None | None |
| GOG-164 | None | None | None |
| CLB-9791 | None | None | None |
| E-G0164 | None | None | None |