Ovarian Cancer Clinical Trial
Official title:
A Phase II Study Of Paclitaxel, Carboplatin And Gemcitabine In Previously Untreated Patients With Epithelial Ovarian Carcinoma FIGO Stage IIB-IV
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.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating
patients who have stage IC, stage IIB, stage III, or stage IV ovarian epithelial, fallopian
tube, or peritoneal cancer that has not been previously treated.
OBJECTIVES:
- Determine the tolerability and toxicity of paclitaxel, carboplatin, and gemcitabine in
patients with previously untreated stage IC-IV ovarian epithelial, fallopian tube, or
peritoneal carcinoma.
- Determine the response rate of patients treated with this regimen.
- Determine the time to progression and overall survival of patients treated with this
regimen.
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
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