Phase I Study of Oral Topotecan as Consolidation for Patients With Mullerian Origin Tumors (Ovary, Tube, Peritoneum)
- 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 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
Stephen A. Cannistra, MD
Beth Israel Deaconess Medical Center
United States: Federal Government
|Beth Israel Deaconess Medical Center||Boston, Massachusetts 02215|