Combination Chemotherapy in Treating Patients With Advanced Ovarian Epithelial Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

1999-08-31

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.

Conditions

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Ovarian Cancer

Keywords

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stage I ovarian epithelial cancer stage II ovarian epithelial cancer stage III ovarian epithelial cancer stage IV ovarian epithelial cancer

Study Design

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Primary Study Purpose

TREATMENT

Interventions

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carboplatin

Intervention Type DRUG

cisplatin

Intervention Type DRUG

paclitaxel

Intervention Type DRUG

topotecan hydrochloride

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Howard S. Hochster, MD

Role: STUDY_CHAIR

NYU Langone Health

Locations

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