Ovarian Cancer Clinical Trial
Official title:
Phase I Study of Weekly Topotecan in Women With Progressive or Recurrent Ovarian Cancer and a Poor Performance Status
RATIONALE: Drugs used in chemotherapy, such as topotecan, work in different ways to stop the
growth of tumor cells, either by killing the cells or by stopping them from dividing.
Chemotherapy drugs may have different effects in patients who have a poor performance status.
PURPOSE: This phase I trial is studying the side effects and best dose of topotecan in
treating patients with progressive or recurrent ovarian epithelial, fallopian tube, or
primary peritoneal cavity cancer with a poor performance status.
OBJECTIVES:
Primary
- 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.
Secondary
- Estimate the response rate of women with poor performance status for use in future
clinical trials.
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
unacceptable toxicity.
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 the
MTD.
Patients are followed periodically for up to 2 years.
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