Ovarian Cancer Clinical Trial
Official title:
A Phase III Randomized Trial of Cisplatin (NSC #119875) With Paclitaxel (NSC #125973) Administered by Either 24 Hour Infusion or 96 Hour Infusion in Patients With Selected Stage III and Stage IV Epithelial Ovarian Cancer and Primary Peritoneal 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 may kill more tumor cells. It is
not yet known which chemotherapy regimen is more effective for ovarian or peritoneal cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of two regimens of
paclitaxel plus cisplatin in treating patients who have residual disease after surgery to
remove stage III or stage IV ovarian cancer or primary peritoneal cancer.
OBJECTIVES: I. Compare progression free and overall survival and frequency of response in
patients with suboptimal stage III or IV ovarian epithelial cancer or primary peritoneal
cancer treated with a 24 hour vs 96 hour infusion of paclitaxel (TAX) followed by cisplatin.
II. Determine the incidence and severity of adverse events, including catheter complications
and drug toxicity, for the 96 hour infusion of TAX. III. Compare the relationship between
plasma TAX concentrations, toxicity, and response to both infusion schedules in this patient
population.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
participating center and measurable disease (yes vs no). Patients are randomized into one of
two treatment arms. Arm I: Patients receive paclitaxel IV continuously over 24 hours
followed by cisplatin IV over 2 hours. Arm II: Patients receive paclitaxel IV continuously
over 96 hours followed by cisplatin IV over 2 hours. Treatment repeats every 3 weeks for 6
courses.
PROJECTED ACCRUAL: A total of 324 patients will be accrued for this study over 4.5 years.
;
Allocation: Randomized, Primary Purpose: Treatment
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