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Gemcitabine Hydrochloride and Docetaxel With or Without Bevacizumab in Treating Patients With Advanced or Recurrent Uterine Leiomyosarcoma

NCT01012297 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 107

Last updated 2020-09-02

Study results available
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Summary

This randomized phase III trial is studying gemcitabine hydrochloride, docetaxel, and bevacizumab to see how well they work compared with gemcitabine hydrochloride, docetaxel, and a placebo in treating patients with advanced or recurrent uterine leiomyosarcoma. Drugs used in chemotherapy, such as gemcitabine hydrochloride and docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. It is not yet known whether gemcitabine hydrochloride and docetaxel are more effective when given with or without bevacizumab in treating uterine leiomyosarcoma.

Conditions

  • Recurrent Uterine Corpus Sarcoma
  • Stage IIIA Uterine Sarcoma
  • Stage IIIB Uterine Sarcoma
  • Stage IIIC Uterine Sarcoma
  • Stage IVA Uterine Sarcoma
  • Stage IVB Uterine Sarcoma
  • Uterine Corpus Leiomyosarcoma

Interventions

BIOLOGICAL

Bevacizumab

Given IV

DRUG

Docetaxel

Given IV

BIOLOGICAL

Filgrastim

Given SC

DRUG

Gemcitabine Hydrochloride

Given IV

BIOLOGICAL

Pegfilgrastim

Given SC

OTHER

Placebo

Given IV

Sponsors & Collaborators

  • NRG Oncology

    collaborator OTHER

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

  • Martee 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
2009-11-30
Primary Completion
2015-09-30
Completion
2015-09-30

Countries

  • United States

Study Locations

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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 NCT01012297 on ClinicalTrials.gov