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Adjuvant Docetaxel Plus Gemcitabine in Patients With Completely Resected Leiomyosarcoma (LMS) of the Uterus

NCT00614835 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2015-12-22

No results posted yet for this study

Summary

This is a pilot study of adjuvant therapy for patients with leiomyosarcoma of the uterus that has been completely removed by surgery. "Adjuvant" therapy means that the tumor (the leiomyosarcoma) has been completely removed by surgery; thus, giving further treatment now is done in hopes of decreasing the chance that the tumor will come back (relapse or recur). The main goal of this study is to show that this series of treatments is safe for patients with your type of tumor.

In this trial you will be getting drugs that have been approved for use in some types of cancer. In this study we wish to see whether the combination of two chemotherapy drugs, docetaxel and gemcitabine can decrease the chance of your tumor, leiomyosarcoma of the uterus, from coming back (relapsing). We will also be looking at the short-term side effects and risks of the drugs given in this combination to patients with leiomyosarcoma that has been completely resected (removed by surgery).

The combination of gemcitabine and docetaxel has been shown to be safe, and it has been shown to decrease the size of leiomyosarcoma tumors in patients with leiomyosarcoma of the uterus that has relapsed, or has continued to grow despite treatment with other chemotherapy drugs.

Conditions

  • Uterine Leiomyosarcoma
  • Uterine Cancer

Interventions

DRUG

Docetaxel plus Gemcitabine

Gemcitabine 900 mg/m2 IV over 90 minutes day 1 Gemcitabine 900 mg/m2 IV over 90 minutes day 8 + Docetaxel 75 mg/m2 IVPB day 8 Dexamethasone 8 mg po bid days 7-9 GCSF 150 ug/m2 (round to nearest vial size: 350 ug or 480 ug) SQ days 9-15 Repeat every 21 days for total of 4 cycles

Sponsors & Collaborators

Principal Investigators

  • Martee Hensley, MD · Memorial Sloan Kettering 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
2001-08-31
Primary Completion
2006-02-28
Completion
2012-01-31

Countries

  • United States

Study Locations

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Entities

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 NCT00614835 on ClinicalTrials.gov