Ovarian Cancer Clinical Trial
Official title:
A PHASE III RANDOMIZED STUDY OF CISPLATIN (NSC #119875) AND TAXOL (PACLITAXEL) (NSC #125973) WITH INTERVAL SECONDARY CYTOREDUCTION VERSUS CISPLATIN AND PACLITAXEL IN PATIENTS WITH SUBOPTIMAL STAGE III & IV EPITHELIAL OVARIAN CARCINOMA
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.
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.
;
Allocation: Randomized, Primary Purpose: Treatment
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