Phase II Study of First-Line Therapy of Ovarian Cancer With Sequential Regimens: Cisplatin-Prolonged Oral Topotecan (C-PORT) Followed by Paclitaxel/Carboplatin (PC)
18 Years
N/A
Female
Ovarian Cancer
Trial Information
Phase II Study of First-Line Therapy of Ovarian Cancer With Sequential Regimens: Cisplatin-Prolonged Oral Topotecan (C-PORT) Followed by Paclitaxel/Carboplatin (PC)
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.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed advanced ovarian epithelial carcinoma, regardless of
quantity of disease post-surgery
- Stage IC, II, III, or IV
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- ECOG 0-2
Life expectancy:
- Not specified
Hematopoietic:
- Absolute neutrophil count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
Hepatic:
- SGOT no greater than 3 times upper limit of normal
- Bilirubin no greater than 2.0 mg/dL
- No clinically significant hepatic disorder
Renal:
- Creatinine no greater than 1.5 mg/dL OR
- Creatinine clearance greater than 60 mL/min
- No clinically significant renal disorder
Cardiovascular:
- No clinically significant cardiovascular condition
Other:
- Normal GI function allowing reliable administration of oral medication
- No active infection requiring systemic medical therapy within past week
- No other clinically significant medical condition (e.g., endocrine/metabolic or
autoimmune disorder)
- No other prior malignancy within the past 5 years except nonmelanoma skin cancer or
carcinoma in situ of the cervix
- No dementia or altered mental status that would preclude consent
- Not pregnant
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- No prior chemotherapy for ovarian epithelial carcinoma
Endocrine therapy:
- Not specified
Radiotherapy:
- No prior radiotherapy for ovarian epithelial carcinoma
Surgery:
- See Disease Characteristics
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Principal Investigator
Howard S. Hochster, MD
Investigator Role:
Study Chair
Investigator Affiliation:
New York University School of Medicine
Authority:
United States: Federal Government
Study ID:
CDR0000067644
NCT ID:
NCT00005051
Start Date:
August 1999
Completion Date:
Related Keywords:
- Ovarian Cancer
- stage I ovarian epithelial cancer
- stage II ovarian epithelial cancer
- stage III ovarian epithelial cancer
- stage IV ovarian epithelial cancer
- Ovarian Neoplasms
- Neoplasms, Glandular and Epithelial
Name | Location |
|---|---|
| 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 |
