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Phase II Study of First-Line Therapy of Ovarian Cancer With Sequential Regimens: Cisplatin-Prolonged Oral Topotecan (C-PORT) Followed by Paclitaxel/Carboplatin (PC)


Phase 2
18 Years
N/A
Not Enrolling
Female
Ovarian Cancer

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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, NYNew York, New York  10029
NYU School of Medicine's Kaplan Comprehensive Cancer CenterNew York, New York  10016
New York Medical CollegeValhalla, New York  10595
University of Wisconsin Comprehensive Cancer CenterMadison, Wisconsin  53792
Albert Einstein Clinical Cancer CenterBronx, New York  10461
Herbert Irving Comprehensive Cancer Center at Columbia UniversityNew York, New York  10032
New York Weill Cornell Cancer Center at Cornell UniversityNew York, New York  10021
Saint Vincent Catholic Medical Center of New YorkNew York, New York  10011
St. Luke's-Roosevelt Hospital Center - Roosevelt DivisionNew York, New York  10019
New York Hospital Medical Center of QueensFresh Meadows, New York  11365