Combination Chemotherapy in Treating Patients With Advanced Ovarian Epithelial Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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)

Conditions
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Ovarian Cancer

Intervention / Treatment
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* Drug: carboplatin
* Drug: cisplatin
* Drug: paclitaxel
* Drug: topotecan hydrochloride


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: carboplatin|nan|
|Drug: cisplatin|nan|
|Drug: paclitaxel|nan|
|Drug: topotecan hydrochloride|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage I ovarian epithelial cancer, stage II ovarian epithelial cancer, stage III ovarian epithelial cancer, stage IV ovarian epithelial cancer