Phase I Study of Weekly Topotecan in Women With Progressive or Recurrent Ovarian Cancer and a Poor Performance Status
- Determine the maximum tolerated dose of weekly topotecan in patients with progressive
or recurrent ovarian epithelial, fallopian tube, or primary peritoneal cavity cancer
and a poor performance status.
- Estimate the response rate of women with poor performance status for use in future
OUTLINE: This is a dose-escalation study.
Patients receive topotecan intravenously (IV) over 30 minutes on days 1, 8, 15, 22, and 29.
Treatment repeats every 42 days for up to 6 courses in the absence of disease progression or
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 preceding that at which 2 of 3 or 2
of 6 patients experience dose-limiting toxicity. A total of 6 patients will be treated at
Patients are followed periodically for up to 2 years.
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Maximum tolerated dose
Levi S. Downs, MD
Masonic Cancer Center, University of Minnesota
United States: Food and Drug Administration
|University of Minnesota Cancer Center||Minneapolis, Minnesota 55455|