A Phase I/II Study to Determine the Maximum Tolerated Doses of Oral Topotecan, Carboplatin and Paclitaxel Administered Every 21 Days to Patients With Epithelial Ovarian Cancer Stages IIb, IIc, III and IV
- 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)
Primary Purpose: Treatment
Maximum tolerated dose and dose-limiting toxicity of topotecan
Svend Aage Engelholm, MD