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
- 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
- Compare response rate, duration of response, and survival time of patients treated with
- 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
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
PROJECTED ACCRUAL: A total of 350 patients will be accrued for this study.
Allocation: Randomized, Primary Purpose: Treatment
Jacobus Pfisterer, MD
University of Schleswig-Holstein
United States: Federal Government
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