A Phase II Study Of Paclitaxel, Carboplatin And Gemcitabine In Previously Untreated Patients With Epithelial Ovarian Carcinoma FIGO Stage IIB-IV
- Determine the tolerability and toxicity of paclitaxel, carboplatin, and gemcitabine in
patients with previously untreated stage IC-IV ovarian epithelial, fallopian tube, or
- Determine the response rate of patients treated with this regimen.
- Determine the time to progression and overall survival of patients treated with this
OUTLINE: This is a multicenter study.
Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1 and
gemcitabine IV over 30-60 minutes on days 1 and 8. Treatment repeats every 3 weeks in the
absence of disease progression or unacceptable toxicity.
Patients are followed at 3 and 6 months.
PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Evaluation of tolerability and toxicity of the combination therapy with paclitaxel, carboplatin and gemcitabine (P-C-G) in first line treatment of ovarian cancer patients. Evaluation of Drop-out rate due to toxicity
The decision level is reached, when the lower exact 95% confidence limit of the observed proportion is higher than the upper exact 95% confidence limit of the historical proportion, which corresponds to a power of 0.5 applying a significance level of 0.05
Based on decision level
Andreas du Bois, MD, PhD
United States: Federal Government