A Phase I Study of Weekly Oral Topotecan in Gynecologic Malignancies
- To establish the maximum tolerated dose (MTD) of oral topotecan hydrochloride in
patients with unresectable gynecologic malignancies.
- To determine the safety and tolerability of this drug in these patients.
- To obtain pharmacokinetic data to assess plasma concentrations of this drug when
administered at the MTD.
- To explore the response in patients treated with this drug.
OUTLINE: Patients receive oral topotecan hydrochloride on days 1, 8, and 15. Treatment
repeats every 28 days for up to 6 courses in the absence of disease progression or
Patients treated at the maximum tolerated dose undergo blood sample collection periodically
on day 1 of course 1 for pharmacokinetic studies.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Maximum tolerated dose (MTD)
Treatment repeats every 28 days for up to 6 courses in the absence of unacceptable toxicity.
Stephen Waggoner, MD
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
United States: Food and Drug Administration
|Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center||Cleveland, Ohio 44106-5065|