Phase II Study of First-Line Therapy of Ovarian Cancer With Sequential Regimens: Cisplatin-Prolonged Oral Topotecan (C-PORT) Followed by Paclitaxel/Carboplatin (PC)
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Ovarian Cancer
- Sponsor
- NYU Langone Health
- Locations
- 10
- Status
- Completed
- Last Updated
- 13 years ago
Overview
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.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating patients who have advanced ovarian epithelial cancer.
Detailed Description
OBJECTIVES: * Determine the toxicity and tolerance of sequential therapy with prolonged * Determine the response rate and time to progression in this patient * Determine the relative pharmacokinetics of IV and prolonged oral administration of topotecan in the same patients and compare the pharmacodynamics of topo-1 inhibition when given by IV or oral route. OUTLINE: * Regimen A: Patients receive cisplatin IV over 60-90 minutes on day 1 of each course. Topotecan IV is administered continuously on days 1-14 of course 1. Oral topotecan is administered twice daily on days 1-14 for courses 2, 3, and 4. Treatment repeats every 28 days for 4 courses. * Regimen B: After completion of regimen A, patients receive paclitaxel IV over 3 hours followed by carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for 4 courses. PROJECTED ACCRUAL: A total of 30 patients (15 per arm) will be accrued for this study.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Not specified