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.
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.
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
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There are 55 Locations for this study
Birmingham Alabama, 35294, United States
Phoenix Arizona, 85006, United States
Los Angeles California, 90033, United States
Los Angeles California, 90095, United States
Orange California, 92868, United States
Palo Alto California, 94304, United States
Stanford California, 94305, United States
Denver Colorado, 80262, United States
Washington District of Columbia, 20007, United States
Washington District of Columbia, 20307, United States
Tampa Florida, 33612, United States
Atlanta Georgia, 30322, United States
Honolulu Hawaii, 96813, United States
Chicago Illinois, 60612, United States
Indianapolis Indiana, 46202, United States
Iowa City Iowa, 52242, United States
Lexington Kentucky, 40536, United States
Baltimore Maryland, 21231, United States
Worcester Massachusetts, 01655, United States
Ann Arbor Michigan, 48106, United States
Detroit Michigan, 48201, United States
Minneapolis Minnesota, 55455, United States
Jackson Mississippi, 39216, United States
Saint Louis Missouri, 63110, United States
Camden New Jersey, 08103, United States
Morristown New Jersey, 07962, United States
Albany New York, 12208, United States
Brooklyn New York, 11203, United States
Manhasset New York, 11030, United States
New York New York, 10021, United States
Rochester New York, 14642, United States
Stony Brook New York, 11790, United States
Chapel Hill North Carolina, 27599, United States
Durham North Carolina, 27710, United States
Winston-Salem North Carolina, 27157, United States
Cincinnati Ohio, 45219, United States
Cleveland Ohio, 44106, United States
Cleveland Ohio, 44195, United States
Columbus Ohio, 43210, United States
Oklahoma City Oklahoma, 73190, United States
Portland Oregon, 97213, United States
Abington Pennsylvania, 19001, United States
Hershey Pennsylvania, 17033, United States
Philadelphia Pennsylvania, 19104, United States
Philadelphia Pennsylvania, 19107, United States
Philadelphia Pennsylvania, 19111, United States
Charleston South Carolina, 29425, United States
Spartanburg South Carolina, 29303, United States
Memphis Tennessee, 38117, United States
Nashville Tennessee, 37203, United States
Dallas Texas, 75235, United States
Houston Texas, 77030, United States
Charlottesville Virginia, 22908, United States
Seattle Washington, 98195, United States
Tacoma Washington, 98405, United States
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