NCT00002717

Paclitaxel and Cisplatin in Treating Patients With Stage III or Stage IV Ovarian Cancer or Primary Peritoneal Cancer

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 324 (estimated)
• Sponsor: Gynecologic Oncology Group · Network
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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 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.

Detailed description

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.

Conditions

• Ovarian Cancer
• Primary Peritoneal Cavity Cancer

Interventions

Type	Name	Description
DRUG	cisplatin
DRUG	paclitaxel

Timeline

• Start date: 1996-03-01
• Primary completion: 2007-10-01
• First posted: 2004-06-22
• Last updated: 2013-05-27

Locations

52 sites across 1 country: United States