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

NCT00842452 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2013-04-05

No results posted yet for this study

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.

Conditions

Interventions

DRUG

topotecan hydrochloride

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.

OTHER

pharmacological study

Patients treated at the maximum tolerated dose undergo blood sample collection periodically on day 1 of course 1 for pharmacokinetic studies.

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Steven Waggoner, MD

    lead OTHER

Principal Investigators

  • Stephen Waggoner, MD · Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-02-28
Primary Completion
2011-04-30
Completion
2011-04-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00842452 on ClinicalTrials.gov