Combination Chemotherapy in Treating Patients With Primary Peritoneal or Stage III Epithelial Ovarian Cancer

NCT ID: NCT00003322

Last Updated: 2013-05-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 384 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1998-03-31

Brief Summary

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 and giving drugs in different ways may kill more tumor cells. It is not yet known whether intravenous two-drug combination chemotherapy is more effective than intravenous and intraperitoneal infusions of three-drug combination chemotherapy for treating primary peritoneal or stage III epithelial ovarian cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of intravenous two-drug combination chemotherapy with intravenous and intraperitoneal three-drug combination chemotherapy in treating patients who have primary peritoneal or stage III epithelial ovarian cancer.

Detailed Description

OBJECTIVES: I. Compare pathological response, recurrence-free interval, and survival in patients with optimal stage III epithelial ovarian cancer or primary peritoneal carcinoma receiving intravenous (IV) paclitaxel and cisplatin vs IV paclitaxel and intraperitoneal (IP) cisplatin plus IP paclitaxel. II. Compare the toxic effects and complications of these 2 treatment regimens in these patients. III. Determine the frequency and prognostic significance of BRCA1 and BRCA2 mutations in these patients. IV. Determine the effect of non-genetic risk factors on the course of disease in BRCA1- and BRCA2-related ovarian cancer or primary peritoneal carcinoma. V. Compare the quality of life of these patients receiving these treatments.

OUTLINE: This is a randomized study. Patients are stratified according to gross residual disease (present vs absent) and whether second-look surgery will be performed at the end of treatment (yes vs no). Blood is drawn for BRCA mutation analysis and DNA extraction before the start of chemotherapy, but after randomization. Patients are randomized to one of two treatment arms. Patients in arm I receive IV paclitaxel by 24-hour infusion on day 1 followed by IV cisplatin on day 2. Patients in arm II receive IV paclitaxel by 24-hour infusion on day 1 followed by intraperitoneal (IP) cisplatin on day 2, plus IP paclitaxel on day 8. Treatment for both arms repeats every 3 weeks for a total of 6 treatment courses. Following chemotherapy, second look surgery is performed if selected by the patient. Quality-of-life assessments are performed prior to randomization, prior to course 4, 3-6 weeks after the completion of course 6 and prior to second look surgery if selected, 6 months after treatment is completed, and 12 months after treatment is completed. Patients are followed every 3 months for 2 years, then every 6 months thereafter.

PROJECTED ACCRUAL: Approximately 384 patients will be accrued for this study within 16 months.

Conditions

Ovarian Cancer; Primary Peritoneal Cavity Cancer

Study Design

• Allocation Method: RANDOMIZED
• Primary Study Purpose: TREATMENT

Interventions

cisplatin

Intervention Type: DRUG

paclitaxel

Intervention Type: DRUG

quality-of-life assessment

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy Surgery: See Disease Characteristics No more than 6 weeks since prior surgery

• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Gynecologic Oncology Group

NETWORK

Sponsor Role: lead

Principal Investigators

Deborah K. Armstrong, MD

Role: STUDY_CHAIR

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Locations

University of Alabama Comprehensive Cancer Center

Birmingham, Alabama, United States

CCOP - Greater Phoenix

Phoenix, Arizona, United States

USC/Norris Comprehensive Cancer Center

Los Angeles, California, United States

Jonsson Comprehensive Cancer Center, UCLA

Los Angeles, California, United States

Chao Family Comprehensive Cancer Center

Orange, California, United States

Women's Cancer Center

Palo Alto, California, United States

University of Colorado Cancer Center

Denver, Colorado, United States

Lombardi Cancer Center, Georgetown University

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

Walter Reed Army Medical Center

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

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, United States

Emory University Hospital - Atlanta

Atlanta, Georgia, United States

CCOP - Atlanta Regional

Atlanta, Georgia, United States

MBCCOP - Hawaii

Honolulu, Hawaii, United States

Rush-Presbyterian-St. Luke's Medical Center

Chicago, Illinois, United States

University of Chicago Cancer Research Center

Chicago, Illinois, United States

CCOP - Central Illinois

Decatur, Illinois, United States

CCOP - Evanston

Evanston, Illinois, United States

Indiana University Cancer Center

Indianapolis, Indiana, United States

University of Iowa Hospitals and Clinics

Iowa City, Iowa, United States

Albert B. Chandler Medical Center, University of Kentucky

Lexington, Kentucky, United States

Johns Hopkins Oncology Center

Baltimore, Maryland, United States

Medicine Branch

Bethesda, Maryland, United States

Radiation Oncology Branch

Bethesda, Maryland, United States

University of Massachusetts Memorial Medical Center

Worcester, Massachusetts, United States

CCOP - Ann Arbor Regional

Ann Arbor, Michigan, United States

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, United States

University of Minnesota Cancer Center

Minneapolis, Minnesota, United States

University of Mississippi Medical Center

Jackson, Mississippi, United States

CCOP - Kansas City

Kansas City, Missouri, United States

Washington University School of Medicine

St Louis, Missouri, United States

CCOP - Montana Cancer Consortium

Billings, Montana, United States

CCOP - Missouri Valley Cancer Consortium

Omaha, Nebraska, United States

CCOP - Southern Nevada Cancer Research Foundation

Las Vegas, Nevada, United States

Cooper Hospital/University Medical Center

Camden, New Jersey, United States

St. Barnabas Medical Center

Livingston, New Jersey, United States

Morristown Memorial Hospital

Morristown, New Jersey, United States

Cancer Center of Albany Medical Center

Albany, New York, United States

State University of New York Health Science Center at Brooklyn

Brooklyn, New York, United States

North Shore University Hospital

Manhasset, New York, United States

Memorial Sloan-Kettering Cancer Center

New York, New York, United States

University of Rochester Cancer Center

Rochester, New York, United States

State University of New York Health Sciences Center - Stony Brook

Stony Brook, New York, United States

Lineberger Comprehensive Cancer Center, UNC

Chapel Hill, North Carolina, United States

Duke Comprehensive Cancer Center

Durham, North Carolina, United States

Comprehensive Cancer Center of Wake Forest University Baptist Medical Center

Winston-Salem, North Carolina, United States

Barrett Cancer Center, The University Hospital

Cincinnati, Ohio, United States

Ireland Cancer Center

Cleveland, Ohio, United States

Cleveland Clinic Cancer Center

Cleveland, Ohio, United States

Arthur G. James Cancer Hospital - Ohio State University

Columbus, Ohio, United States

University of Oklahoma College of Medicine

Oklahoma City, Oklahoma, United States

CCOP - Sooner State

Tulsa, Oklahoma, United States

CCOP - Columbia River Program

Portland, Oregon, United States

Abington Memorial Hospital

Abington, Pennsylvania, United States

Milton S. Hershey Medical Center

Hershey, Pennsylvania, United States

University of Pennsylvania Cancer Center

Philadelphia, Pennsylvania, United States

Kimmel Cancer Center of Thomas Jefferson University - Philadelphia

Philadelphia, Pennsylvania, United States

Fox Chase Cancer Center

Philadelphia, Pennsylvania, United States

Medical University of South Carolina

Charleston, South Carolina, United States

CCOP - Upstate Carolina

Spartanburg, South Carolina, United States

CCOP - Baptist Cancer Institute

Memphis, Tennessee, United States

Brookview Research, Inc.

Nashville, Tennessee, United States

Simmons Cancer Center - Dallas

Dallas, Texas, United States

University of Texas - MD Anderson Cancer Center

Houston, Texas, United States

Cancer Center, University of Virginia HSC

Charlottesville, Virginia, United States

University of Washington Medical Center

Seattle, Washington, United States

Tacoma General Hospital

Tacoma, Washington, United States

Tom Baker Cancer Center - Calgary

Calgary, Alberta, Canada

Countries

United States; Canada

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Other Identifiers

GOG-0172

Identifier Type: -

Identifier Source: secondary_id

CDR0000066273

Identifier Type: -

Identifier Source: org_study_id