Docetaxel, Gemcitabine, and Filgrastim (G-CSF) or Pegfilgrastim in Treating Patients With Advanced, Persistent, or Recurrent Uterine Leiomyosarcoma

NCT00101127 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2014-02-14

No results posted yet for this study

Summary

RATIONALE: Drugs used in chemotherapy, such as docetaxel and gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Colony-stimulating factors, such as G-CSF and pegfilgrastim, may increase the number of immune cells found in bone marrow or peripheral blood and may help the immune system recover from the side effects of chemotherapy. Giving docetaxel and gemcitabine together with G-CSF or pegfilgrastim may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving docetaxel and gemcitabine together with G-CSF or pegfilgrastim works in treating patients with advanced, persistent, or recurrent uterine leiomyosarcoma.

Conditions

  • Sarcoma

Interventions

BIOLOGICAL

filgrastim

BIOLOGICAL

pegfilgrastim

DRUG

docetaxel

DRUG

gemcitabine hydrochloride

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH
  • Gynecologic Oncology Group

    lead NETWORK

Principal Investigators

  • Martee L. Hensley, MD · Memorial Sloan Kettering Cancer Center

  • Gregory P. Sutton, MD · St. Vincent Gynecologic Oncology at St. Vincent Oncology Center

Study Design

Purpose
TREATMENT
Masking
NONE

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-12-31
Primary Completion
2006-07-31

Countries

  • United States

Study Locations

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Entities

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 NCT00101127 on ClinicalTrials.gov