Adjuvant Docetaxel Plus Gemcitabine in Patients With Completely Resected Leiomyosarcoma (LMS) of the Uterus
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.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Pilot Study of Adjuvant Docetaxel Plus Gemcitabine in Patients With Completely Resected Leiomyosarcoma (LMS) of the Uterus|
- To determine the tolerability of delivering 4 cycles of docetaxel plus gemcitabine. [ Time Frame: conclusion of the study ] [ Designated as safety issue: Yes ]
- 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 ] [ Designated as safety issue: No ]
|Study Start Date:||August 2001|
|Study Completion Date:||January 2012|
|Primary Completion Date:||February 2006 (Final data collection date for primary outcome measure)|
Experimental: 1 patients with completely resected uterine leiomyosarcoma
Docetaxel plus Gemcitabine
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00614835
|United States, New York|
|Memorial Sloan Kettering Cancer Center|
|New York, New York, United States, 10065|
|Principal Investigator:||Martee Hensley, MD||Memorial Sloan Kettering Cancer Center|