Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002717
Status:
COMPLETED
Last Update Posted:
2013-05-27
First Post:
1999-11-01
Brief Title:
Paclitaxel and Cisplatin in Treating Patients With Stage III or Stage IV Ovarian Cancer or Primary Peritoneal Cancer
Sponsor:
Gynecologic Oncology Group
Organization:
GOG Foundation
Study Overview
Official Title:
A Phase III Randomized Trial of Cisplatin NSC 119875 With Paclitaxel NSC 125973 Administered by Either 24 Hour Infusion or 96 Hour Infusion in Patients With Selected Stage III and Stage IV Epithelial Ovarian Cancer and Primary Peritoneal Carcinoma
Status:
COMPLETED
Status Verified Date:
2010-01
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 which chemotherapy regimen is more effective for ovarian or peritoneal cancer
PURPOSE Randomized phase III trial to compare the effectiveness of two regimens of paclitaxel plus cisplatin in treating patients who have residual disease after surgery to remove stage III or stage IV ovarian cancer or primary peritoneal cancer
PURPOSE Randomized phase III trial to compare the effectiveness of two regimens of paclitaxel plus cisplatin in treating patients who have residual disease after surgery to remove stage III or stage IV ovarian cancer or primary peritoneal cancer
Detailed Description:
OBJECTIVES I Compare progression free and overall survival and frequency of response in patients with suboptimal stage III or IV ovarian epithelial cancer or primary peritoneal cancer treated with a 24 hour vs 96 hour infusion of paclitaxel TAX followed by cisplatin II Determine the incidence and severity of adverse events including catheter complications and drug toxicity for the 96 hour infusion of TAX III Compare the relationship between plasma TAX concentrations toxicity and response to both infusion schedules in this patient population
OUTLINE This is a randomized multicenter study Patients are stratified according to participating center and measurable disease yes vs no Patients are randomized into one of two treatment arms Arm I Patients receive paclitaxel IV continuously over 24 hours followed by cisplatin IV over 2 hours Arm II Patients receive paclitaxel IV continuously over 96 hours followed by cisplatin IV over 2 hours Treatment repeats every 3 weeks for 6 courses
PROJECTED ACCRUAL A total of 324 patients will be accrued for this study over 45 years
OUTLINE This is a randomized multicenter study Patients are stratified according to participating center and measurable disease yes vs no Patients are randomized into one of two treatment arms Arm I Patients receive paclitaxel IV continuously over 24 hours followed by cisplatin IV over 2 hours Arm II Patients receive paclitaxel IV continuously over 96 hours followed by cisplatin IV over 2 hours Treatment repeats every 3 weeks for 6 courses
PROJECTED ACCRUAL A total of 324 patients will be accrued for this study over 45 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 |
|---|---|---|---|
| GOG-0162 | None | None | None |