Finding studies
Finding studies
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Lead
Copenhagen University Hospital, Rigshospitalet
OBJECTIVES: * Determine the maximum tolerated dose, dose-limiting toxicity, and quantitative and qualitative toxic effects of oral topotecan combined with intravenous carboplatin and paclitaxel in patients with stage IIB, IIC, III, or IV ovarian epithelial cancer. (phase I closed to accrual 12/21/00) * Evaluate the anti-tumor activity of this regimen in this patient population. OUTLINE: This is a multicenter, dose-escalation study of topotecan. Patients receive oral topotecan on days 1-5 and paclitaxel IV over 3 hours followed by carboplatin IV over 30 minutes on day 5. Courses repeat every 21 days for a maximum of 6 courses in the absence of disease progression or unacceptable toxicity. * Phase I: Cohorts of 3-6 patients receive escalating doses of topotecan until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 2 of 6 patients experience dose-limiting toxicity. (phase I closed to accrual 12/21/00) * Phase II: An additional 50 patients receive up to 6 courses of treatment as in phase I at the MTD. Patients are followed every 3 months for 2 years and then every 6 months for 3 years. PROJECTED ACCRUAL: A total of 80 patients (30 in phase I and 50 in phase II) will be accrued for this study. (phase I closed to accrual 12/21/00)
Age
18–any
Sex
FEMALE
Healthy volunteers
Not accepted
