Combination Chemotherapy in Treating Patients With Advanced Ovarian Epithelial Cancer
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|ClinicalTrials.gov Identifier: NCT00005051|
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : November 9, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|Ovarian Cancer||Drug: carboplatin Drug: cisplatin Drug: paclitaxel Drug: topotecan hydrochloride||Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Official Title:||Phase II Study of First-Line Therapy of Ovarian Cancer With Sequential Regimens: Cisplatin-Prolonged Oral Topotecan (C-PORT) Followed by Paclitaxel/Carboplatin (PC)|
|Study Start Date :||August 1999|
|Actual Primary Completion Date :||March 2003|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00005051
|United States, New York|
|Albert Einstein Clinical Cancer Center|
|Bronx, New York, United States, 10461|
|New York Hospital Medical Center of Queens|
|Fresh Meadows, New York, United States, 11365|
|Saint Vincent Catholic Medical Center of New York|
|New York, New York, United States, 10011|
|NYU School of Medicine's Kaplan Comprehensive Cancer Center|
|New York, New York, United States, 10016|
|St. Luke's-Roosevelt Hospital Center - Roosevelt Division|
|New York, New York, United States, 10019|
|New York Weill Cornell Cancer Center at Cornell University|
|New York, New York, United States, 10021|
|Mount Sinai Medical Center, NY|
|New York, New York, United States, 10029|
|Herbert Irving Comprehensive Cancer Center at Columbia University|
|New York, New York, United States, 10032|
|New York Medical College|
|Valhalla, New York, United States, 10595|
|United States, Wisconsin|
|University of Wisconsin Comprehensive Cancer Center|
|Madison, Wisconsin, United States, 53792-3236|
|Study Chair:||Howard S. Hochster, MD||New York University School of Medicine|