NCT00006453

Carboplatin With or Without Gemcitabine in Treating Patients With Advanced Ovarian Epithelial Cancer That Has Not Responded to Previous Chemotherapy

A Randomized Phase III Study Comparing Gemcitabine Plus Carboplatin Versus Carboplatin Monotherapy in Patients With Advanced Epithelial Ovarian Carcinoma Who Failed First-Line Platinum-Based Therapy

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: —
• Sponsor: AGO Study Group · Academic / Other
• Sex: Female
• Age: 18 Years – 120 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 if carboplatin is more effective with or without gemcitabine for ovarian epithelial cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of carboplatin with or without gemcitabine in treating patients who have advanced ovarian epithelial cancer that has not responded to previous chemotherapy.

Detailed description

OBJECTIVES: * Compare time to progression in patients with advanced ovarian epithelial carcinoma who failed prior first-line platinum-based therapy when treated with carboplatin with or without gemcitabine. * Compare response rate, duration of response, and survival time of patients treated with these regimens. * Compare the toxicity of these treatment regimens in these patients. * Compare quality of life of patients treated with these regimens. OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to progression-free time (6-12 months vs more than 12 months), type of prior first-line therapy, and bidimensionally measurable disease (yes vs no). Patients are randomized to one of two treatment arms. * Arm I: Patients receive carboplatin IV over 30-60 minutes on day 1 and gemcitabine IV over 30-60 minutes on days 1 and 8. * Arm II: Patients receive carboplatin IV as in arm I. Treatment in both arms repeats every 3 weeks for up to 6-8 courses in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at baseline, before each subsequent chemotherapy course, and at 50 days after study. Patients are followed at 50 days, every 2 months for 1 year, and then every 3 months for 1 year. PROJECTED ACCRUAL: A total of 350 patients will be accrued for this study.

Conditions

• Ovarian Cancer

Interventions

Type	Name	Description
DRUG	carboplatin
DRUG	gemcitabine hydrochloride

Timeline

• Start date: 1999-09-01
• Primary completion: 2006-10-01
• Completion: 2006-10-01
• First posted: 2003-07-28
• Last updated: 2015-12-23

Locations

74 sites across 2 countries: United States, Canada