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Chemotherapy With or Without Peripheral Stem Cell Transplantation in Treating Patients With Persistent Ovarian Epithelial Cancer

Last Updated: 2013-04-11

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

TERMINATED

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

1996-11-30

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. Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy or radiation therapy used to kill tumor cells. It is not yet known whether chemotherapy alone is more effective than chemotherapy plus peripheral stem cell transplantation for ovarian epithelial cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of paclitaxel and carboplatin with that of carboplatin, mitoxantrone, and cyclophosphamide followed by peripheral stem cell transplantation in treating patients who have persistent stage III or stage IV ovarian epithelial cancer.

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Detailed Description

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OBJECTIVES: I. Compare progression-free and overall survival of patients with drug-sensitive, low-volume ovarian cancer that is persistent following standard therapy treated with salvage therapy comprising standard-dose paclitaxel and carboplatin vs high-dose carboplatin, mitoxantrone, and cyclophosphamide followed by bone marrow reconstitution. II. Compare the toxic effects of these two salvage regimens. III. Compare selected health-related aspects of quality of life in these patients.

OUTLINE: This is a randomized, multicenter study. Patients are stratified by participating center and disease state at reassessment laparotomy. Patients are randomized to one of two treatment arms. Arm I: Patients receive paclitaxel IV over 3 hours on day 1 and carboplatin IV continuously on days 1-5 every 3 weeks for a total of 6 courses. Arm II: Patients receive cyclophosphamide IV over 1 hour and mitoxantrone IV over 15 minutes on days -8, -6, and -4, and carboplatin IV continuously on days -8 through -4, followed by rescue with autologous bone marrow or peripheral blood stem cells on day 0. Quality of life is assessed at baseline, at 3 and 9 weeks after starting treatment, and every 3 months for an additional 5 assessments regardless of disease progression.

PROJECTED ACCRUAL: A total of 275 patients will be accrued over approximately 60 months.

Conditions

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Ovarian Cancer

Study Design

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Allocation Method

RANDOMIZED

Primary Study Purpose

TREATMENT

Interventions

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carboplatin

Intervention Type DRUG

cyclophosphamide

Intervention Type DRUG

mitoxantrone hydrochloride

Intervention Type DRUG

paclitaxel

Intervention Type DRUG

autologous bone marrow transplantation

Intervention Type PROCEDURE

peripheral blood stem cell transplantation

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

PATIENT CHARACTERISTICS: Age: Under 66 Performance status: GOG 0 or 1 Hematopoietic: Absolute granulocyte count at least 1,000/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 mg/dL AST no greater than 3 times normal Renal: Creatinine clearance at least 60 mL/min Cardiovascular: Left ventricular ejection fraction at least 45% by MUGA No congestive heart failure Pulmonary: FEV1 and FVC at least 60% Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No prior malignancy in the past 5 years except adequately treated nonmelanomatous skin cancer, carcinoma in situ of the cervix, or any other cancer whose prior treatment does not contraindicate this study

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics At least 4 and no more than 6 prior platinum-based combination chemotherapy courses (i.e., cisplatin or carboplatin) required Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: See Disease Characteristics Other: No prior anthracyclines

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Principal Investigators

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William P. McGuire, MD

Role: STUDY_CHAIR

Harry and Jeanette Weinberg Cancer Institute at Franklin Square Hospital Center

Kenneth B. Miller, MD

Role: STUDY_CHAIR

Tufts Medical Center Cancer Center

Patrick J. Stiff, MD

Role: STUDY_CHAIR

Loyola University

Stephen L. Graziano, MD

Role: STUDY_CHAIR

State University of New York - Upstate Medical University

Locations

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Veterans Affairs Medical Center - Birmingham

Birmingham, Alabama, United States

Site Status

University of California San Diego Cancer Center

La Jolla, California, United States

Site Status

UCSF Cancer Center and Cancer Research Institute

San Francisco, California, United States

Site Status

Veterans Affairs Medical Center - San Francisco

San Francisco, California, United States

Site Status

CCOP - Christiana Care Health Services

Wilmington, Delaware, United States

Site Status

Walter Reed Army Medical Center

Washington D.C., District of Columbia, United States

Site Status

Sylvester Cancer Center, University of Miami

Miami, Florida, United States

Site Status

CCOP - Mount Sinai Medical Center

Miami Beach, Florida, United States

Site Status