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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Pilot Study of Adjuvant Docetaxel Plus Gemcitabine in Patients With Completely Resected Leiomyosarcoma (LMS) of the Uterus

Brief 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.

Detailed Summary:
Sponsor: Memorial Sloan Kettering Cancer Center

Current Primary Outcome: To determine the tolerability of delivering 4 cycles of docetaxel plus gemcitabine. [ Time Frame: conclusion of the study ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Determine the percentage of pts with completely resected uterine LMS tx with the regimen that remain progression-free at 2 years, & compare this rate with historical controls to establish an estimate of the efficacy of the adjuvant treatment strategy. [ Time Frame: conclusion of the study ]

Original Secondary Outcome: Same as current

Information By: Memorial Sloan Kettering Cancer Center

Dates:
Date Received: January 31, 2008
Date Started: August 2001
Date Completion:
Last Updated: December 21, 2015
Last Verified: December 2015