Ovarian Cancer Clinical Trial

Combination Chemotherapy With or Without Surgery in Treating Patients With Stage III Ovarian Epithelial Cancer

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 or combining chemotherapy with surgery may kill more tumor cells.

PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy consisting of paclitaxel and cisplatin with or without surgery in treating patients with stage III ovarian epithelial cancer.

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Full Description

OBJECTIVES: I. Determine whether secondary cytoreductive surgery improves the progression-free interval and survival in patients with suboptimally resected stage III ovarian epithelial carcinoma treated with paclitaxel/cisplatin. II. Determine the morbidity of secondary cytoreductive surgery in these patients. III. Assess prospectively the quality of life (QOL) of these patients and determine whether secondary cytoreductive surgery affects QOL.

OUTLINE: Randomized study. Following treatment on Regimen A, patients with stable or objective response are randomized to Arms I and II. Regimen A: 2-Drug Combination Chemotherapy. Paclitaxel (Bristol-Myers), Taxol, NSC-125973; Cisplatin, CDDP, NSC-119875. Arm I: Surgery followed by 2-Drug Combination Chemotherapy. Laparotomy with resection of residual disease; followed by Taxol/CDDP. Arm II: 2-Drug Combination Chemotherapy. Taxol; CDDP.

PROJECTED ACCRUAL: Approximately 470 patients will be entered over 20 months to provide 400 evaluable patients.

View Eligibility Criteria

Eligibility Criteria

DISEASE CHARACTERISTICS: Histologically confirmed primary ovarian epithelial cancer Stage III disease, i.e.: Greater than 1 cm residual intraperitoneal disease following exploratory laparotomy with maximum debulking Laparoscopic resection alone insufficient The following histologies are eligible: Serous adenocarcinoma Transitional cell carcinoma Mucinous adenocarcinoma Undifferentiated carcinoma Clear cell adenocarcinoma Mixed epithelial carcinoma Adenocarcinoma Endometrioid tumor Adenocarcinoma NOS Malignant Brenner's tumor No unclassified ovarian cancer (i.e., unexplored tumors thought to be of ovarian origin or tumors not verified as arising from ovarian stroma) No borderline (grade 0) or "probably malignant" carcinoma Measurable disease preferred Patients eligible for this protocol are also eligible for protocol GOG-136

PATIENT CHARACTERISTICS: Age: Any age Performance status: GOG 0-2 Hematopoietic: WBC at least 3,000/mm3 Absolute granulocyte count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no more than 1.5 times normal ALT, AST, and GGT no more than 3 times normal Alkaline phosphatase no more than 3 times normal LDH no more than 3 times normal Renal: Creatinine no more than 2.0 mg/dL Cardiovascular: No history of congestive heart failure No myocardial infarction within 6 months No unstable angina Other: No septicemia or severe infection No acute hepatitis No severe gastrointestinal bleeding No second malignancy within 5 years except nonmelanomatous skin cancer Not pregnant or nursing Effective contraception required of fertile patients

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

Study is for people with:

Ovarian Cancer

Phase:

Phase 3

Estimated Enrollment:

470

Study ID:

NCT00002568

Recruitment Status:

Completed

Sponsor:

Gynecologic Oncology Group

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There are 55 Locations for this study

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University of Alabama Comprehensive Cancer Center
Birmingham Alabama, 35294, United States
CCOP - Greater Phoenix
Phoenix Arizona, 85006, United States
USC/Norris Comprehensive Cancer Center
Los Angeles California, 90033, United States
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles California, 90095, United States
Chao Family Comprehensive Cancer Center
Orange California, 92868, United States
Women's Cancer Center
Palo Alto California, 94304, United States
Stanford University Medical Center
Stanford California, 94305, United States
University of Colorado Cancer Center
Denver Colorado, 80262, United States
Lombardi Cancer Center, Georgetown University
Washington District of Columbia, 20007, United States
Walter Reed Army Medical Center
Washington District of Columbia, 20307, United States
H. Lee Moffitt Cancer Center and Research Institute
Tampa Florida, 33612, United States
Emory University Hospital - Atlanta
Atlanta Georgia, 30322, United States
MBCCOP - Hawaii
Honolulu Hawaii, 96813, United States
Rush-Presbyterian-St. Luke's Medical Center
Chicago Illinois, 60612, United States
Indiana University Cancer Center
Indianapolis Indiana, 46202, United States
University of Iowa Hospitals and Clinics
Iowa City Iowa, 52242, United States
Albert B. Chandler Medical Center, University of Kentucky
Lexington Kentucky, 40536, United States
Johns Hopkins Oncology Center
Baltimore Maryland, 21231, United States
University of Massachusetts Memorial Medical Center
Worcester Massachusetts, 01655, United States
CCOP - Ann Arbor Regional
Ann Arbor Michigan, 48106, United States
Barbara Ann Karmanos Cancer Institute
Detroit Michigan, 48201, United States
University of Minnesota Cancer Center
Minneapolis Minnesota, 55455, United States
University of Mississippi Medical Center
Jackson Mississippi, 39216, United States
Washington University School of Medicine
Saint Louis Missouri, 63110, United States
Cooper Hospital/University Medical Center
Camden New Jersey, 08103, United States
Morristown Memorial Hospital
Morristown New Jersey, 07962, United States
Cancer Center of Albany Medical Center
Albany New York, 12208, United States
State University of New York Health Science Center at Brooklyn
Brooklyn New York, 11203, United States
North Shore University Hospital
Manhasset New York, 11030, United States
Memorial Sloan-Kettering Cancer Center
New York New York, 10021, United States
University of Rochester Cancer Center
Rochester New York, 14642, United States
State University of New York Health Sciences Center - Stony Brook
Stony Brook New York, 11790, United States
Lineberger Comprehensive Cancer Center, UNC
Chapel Hill North Carolina, 27599, United States
Duke Comprehensive Cancer Center
Durham North Carolina, 27710, United States
Comprehensive Cancer Center of Wake Forest University Baptist Medical Center
Winston-Salem North Carolina, 27157, United States
Barrett Cancer Center, The University Hospital
Cincinnati Ohio, 45219, United States
Ireland Cancer Center
Cleveland Ohio, 44106, United States
Cleveland Clinic Taussig Cancer Center
Cleveland Ohio, 44195, United States
Arthur G. James Cancer Hospital - Ohio State University
Columbus Ohio, 43210, United States
University of Oklahoma College of Medicine
Oklahoma City Oklahoma, 73190, United States
CCOP - Columbia River Program
Portland Oregon, 97213, United States
Abington Memorial Hospital
Abington Pennsylvania, 19001, United States
Milton S. Hershey Medical Center
Hershey Pennsylvania, 17033, United States
University of Pennsylvania Cancer Center
Philadelphia Pennsylvania, 19104, United States
Kimmel Cancer Center of Thomas Jefferson University - Philadelphia
Philadelphia Pennsylvania, 19107, United States
Fox Chase Cancer Center
Philadelphia Pennsylvania, 19111, United States
Medical University of South Carolina
Charleston South Carolina, 29425, United States
CCOP - Upstate Carolina
Spartanburg South Carolina, 29303, United States
CCOP - Baptist Cancer Institute
Memphis Tennessee, 38117, United States
Brookview Research, Inc.
Nashville Tennessee, 37203, United States
Simmons Cancer Center - Dallas
Dallas Texas, 75235, United States
University of Texas - MD Anderson Cancer Center
Houston Texas, 77030, United States
Cancer Center, University of Virginia HSC
Charlottesville Virginia, 22908, United States
University of Washington Medical Center
Seattle Washington, 98195, United States
Tacoma General Hospital
Tacoma Washington, 98405, United States

How clear is this clinincal trial information?

Study is for people with:

Ovarian Cancer

Phase:

Phase 3

Estimated Enrollment:

470

Study ID:

NCT00002568

Recruitment Status:

Completed

Sponsor:


Gynecologic Oncology Group

How clear is this clinincal trial information?

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