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Topotecan, Cisplatin, and Radiation Therapy in Treating Patients With Advanced Cervical Cancer

NCT00287911 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2017-12-02

No results posted yet for this study

Summary

RATIONALE: Drugs used in chemotherapy, such as topotecan and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high energy x-rays to kill tumor cells. Internal radiation uses radioactive material placed directly into or near a tumor to kill tumor cells. Topotecan and cisplatin may make tumor cells more sensitive to radiation therapy. Giving topotecan and cisplatin together with radiation therapy may kill more tumor cells.

PURPOSE: This phase I trial is studying the side effects and best dose of topotecan when given together with cisplatin and radiation therapy in treating patients with advanced cervical cancer.

Conditions

Interventions

DRUG

cisplatin

intravenously (IV) over 1 hour on days 1, 8, 15, 22, 29, and 36

DRUG

topotecan hydrochloride

intravenously continuously on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36 -Cohorts of 3-6 patients receive escalating doses of topotecan until the maximum tolerated dose (MTD) is determined

RADIATION

brachytherapy

Some patients may also undergo brachytherapy

RADIATION

radiation therapy

once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36

Sponsors & Collaborators

  • GlaxoSmithKline

    collaborator INDUSTRY

  • Masonic Cancer Center, University of Minnesota

    lead OTHER

Principal Investigators

  • Linda F. Carson, MD · Masonic Cancer Center, University of Minnesota

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-02-28
Primary Completion
2009-12-31
Completion
2009-12-31

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
Companies

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 NCT00287911 on ClinicalTrials.gov