Phase II Study of First-Line Therapy of Ovarian Cancer With Sequential Regimens: Cisplatin-Prolonged Oral Topotecan (C-PORT) Followed by Paclitaxel/Carboplatin (PC)
- 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.
- 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.
Primary Purpose: Treatment
Howard S. Hochster, MD
New York University School of Medicine
United States: Federal Government
|Mount Sinai Medical Center, NY||New York, New York 10029|
|NYU School of Medicine's Kaplan Comprehensive Cancer Center||New York, New York 10016|
|New York Medical College||Valhalla, New York 10595|
|University of Wisconsin Comprehensive Cancer Center||Madison, Wisconsin 53792|
|Albert Einstein Clinical Cancer Center||Bronx, New York 10461|
|Herbert Irving Comprehensive Cancer Center at Columbia University||New York, New York 10032|
|New York Weill Cornell Cancer Center at Cornell University||New York, New York 10021|
|Saint Vincent Catholic Medical Center of New York||New York, New York 10011|
|St. Luke's-Roosevelt Hospital Center - Roosevelt Division||New York, New York 10019|
|New York Hospital Medical Center of Queens||Fresh Meadows, New York 11365|