Topotecan in Treating Patients With Gynecologic Cancer That Cannot Be Removed by Surgery

Phase 1

Completed

• Conditions: Cervical Cancer; Endometrial Cancer; Fallopian Tube Cancer; Ovarian Cancer; Sarcoma; Vaginal Cancer; Vulvar Cancer
• Interventions: Drug: topotecan hydrochloride; Other: pharmacological study

• Registration Number: NCT00842452
• Lead Sponsor: Steven Waggoner, MD

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.

Study Timeline

• Study Start: 2009-02
• Study First Submitted: 2009-02-11
• Study First Submitted QC: 2009-02-11
• Study First Posted: 2009-02-12
• Primary Completion: 2011-04
• Study Completion: 2011-04
• Status Verified: 2013-04
• Last Update Submitted: 2013-04-03
• Last Update Posted: 2013-04-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 26

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Oral Topotecan	topotecan hydrochloride	-
Oral Topotecan	pharmacological study	-

Primary Outcome Measures

Name	Time	Method
Maximum tolerated dose (MTD)	Treatment repeats every 28 days for up to 6 courses in the absence of unacceptable toxicity.
Safety and tolerability	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	blood sample collection periodically on day 1 of course 1 for pharmacokinetic studies

Secondary Outcome Measures

Name	Time	Method
Response	Treatment repeats every 28 days for up to 6 courses in the absence of disease progression.

Trial Locations

Locations (1)

Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center; 🇺🇸 Cleveland, Ohio, United States