Combination Chemotherapy in Treating Patients With Advanced Ovarian Epithelial Cancer

NYU Langone Health

Overview

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.

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.

Study Type

INTERVENTIONAL

Purpose

TREATMENT

Conditions

Ovarian Cancer

Interventions

carboplatinDRUG

cisplatinDRUG

paclitaxelDRUG

topotecan hydrochlorideDRUG

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (10)

New York Hospital Medical Center of Queens

Fresh Meadows, New York, United States

Saint Vincent Catholic Medical Center of New York

New York, New York, United States

NYU School of Medicine's Kaplan Comprehensive Cancer Center

New York, New York, United States

Data from ClinicalTrials.gov

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