Ovarian Cancer Clinical Trial
Official title:
Phase I Study of Oral Topotecan as Consolidation for Patients With Mullerian Origin Tumors (Ovary, Tube, Peritoneum)
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing
so they stop growing or die.
PURPOSE: Phase I trial to study the effectiveness of topotecan in treating patients who have
advanced ovarian epithelial, fallopian tube, or primary peritoneal cancer.
OBJECTIVES:
- Determine the maximum tolerated dose and duration of prolonged topotecan as maintenance
in patients with advanced ovarian epithelial, fallopian tube, or primary peritoneal
cancer with complete clinical response after platinum-based chemotherapy.
- Determine the safety of this regimen in these patients.
OUTLINE: This is a dose-escalation study.
Patients receive oral topotecan twice daily for 21 days. Treatment repeats every 28 days for
up to 6 months in the absence of unacceptable toxicity or disease progression.
Patients who tolerate course 1 may receive an escalated dose of topotecan for subsequent
courses. The maximum tolerated dose is defined as the dose tolerated by the majority of the
patients.
Patients are followed every 2 months for at least 6 months.
PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.
;
Primary Purpose: Treatment
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