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Gemcitabine Hydrochloride and Docetaxel Followed by Doxorubicin Hydrochloride or Observation in Treating Patients With High-Risk Uterine Leiomyosarcoma Previously Removed by Surgery

NCT01533207 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2020-04-28

Study results available
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Summary

This randomized phase III trial studies how well gemcitabine hydrochloride and docetaxel followed by doxorubicin hydrochloride work compared to observation in treating patients with high-risk uterine leiomyosarcoma previously removed by surgery. Drugs used in chemotherapy, such as gemcitabine hydrochloride, docetaxel, and doxorubicin hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether combination therapy after surgery is an effective treatment for uterine leiomyosarcoma.

Conditions

  • Stage I Uterine Sarcoma AJCC v7
  • Uterine Corpus Leiomyosarcoma

Interventions

OTHER

Clinical Observation

Patients followed clinically

DRUG

Docetaxel

Given IV

DRUG

Doxorubicin Hydrochloride

Given IV

BIOLOGICAL

Filgrastim

Given subcutaneously (SC)

DRUG

Gemcitabine Hydrochloride

Given IV

BIOLOGICAL

Pegfilgrastim

Given SC

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Gynecologic Oncology Group

    lead NETWORK

Principal Investigators

  • Martee L Hensley · NRG Oncology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-06-04
Primary Completion
2018-06-30
Completion
2019-02-09

Countries

  • United States
  • Belgium
  • France
  • Netherlands
  • Norway
  • Spain
  • United Kingdom
  • Venezuela

Study Locations

More Related Trials

Entities

Drugs

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 NCT01533207 on ClinicalTrials.gov