A Phase I Study of Weekly Oral Topotecan in Gynecologic Malignancies
Overview
- Phase
- Phase 1
- Intervention
- topotecan hydrochloride
- Conditions
- Cervical Cancer
- Sponsor
- Steven Waggoner, MD
- Enrollment
- 26
- Locations
- 1
- Primary Endpoint
- Maximum tolerated dose (MTD)
- Status
- Completed
- Last Updated
- 13 years ago
Overview
Brief Summary
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.
PURPOSE: This phase I trial is studying the side effects and best dose of topotecan in treating patients with gynecologic cancer that cannot be removed by surgery.
Detailed Description
OBJECTIVES: Primary * 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. Secondary * 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 unacceptable toxicity. Patients treated at the maximum tolerated dose undergo blood sample collection periodically on day 1 of course 1 for pharmacokinetic studies.
Investigators
Steven Waggoner, MD
Principal Investigator
Case Comprehensive Cancer Center
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Oral Topotecan
Intervention: topotecan hydrochloride
Oral Topotecan
Intervention: pharmacological study
Outcomes
Primary Outcomes
Maximum tolerated dose (MTD)
Time Frame: Treatment repeats every 28 days for up to 6 courses in the absence of unacceptable toxicity.
Safety and tolerability
Time Frame: Treatment repeats every 28 days for up to 6 courses in the absence of unacceptable toxicity.
Plasma concentration of topotecan hydrochloride when administered at the MTD
Time Frame: blood sample collection periodically on day 1 of course 1 for pharmacokinetic studies
Secondary Outcomes
- Response(Treatment repeats every 28 days for up to 6 courses in the absence of disease progression.)