Comparison of Gemcitabine v. Gemcitabine Plus Docetaxel in Unresectable Soft Tissue Sarcoma
The purpose of this study is to compare the drug gemcitabine to two drugs, gemcitabine and docetaxel, to find out which treatment is better for people with sarcomas.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Ph III Random Trial of 120-Min Infusion Gemcitabine v. 90-Min Infusion Gemcitabine + Docetaxel in Unresectable Soft Tissue Sarcoma: A Multi-Disciplinary Trial of the North Amer. Sarcoma Study Group of the Connective Tissue Oncology Society|
- Determine whether the failure rate (defined as progression or death) among patients with unresectable soft tissue sarcoma is improved with gemcitabine plus docetaxel compared with gemcitabine alone
- Determine whether the failure rate (defined as progression or death) at 3 and 6 months is improved among patients with unresectable soft tissue sarcoma treated with gemcitabine plus docetaxel compared with those treated with gemcitabine alone.
- Overall survival will be evaluated
- Response rate will be evaluated
- Toxicity will be evaluated
|Study Start Date:||January 2003|
|Study Completion Date:||September 2007|
This research is being done because better treatments for sarcomas are needed. This is a phase III study. This means that one treatment is being compared to another to find out which is better. We are comparing the drug gemcitabine to the two drugs gemcitabine and docetaxel to find out which treatment is better for people who have sarcomas. From previous studies we know that gemcitabine causes shrinking of some people's sarcoma tumors. We also know that gemcitabine and docetaxel are useful for sarcomas as well, but we believe the two drugs together may be more toxic than the single drug alone. In this study we are trying to answer the question: "Is the combination of gemcitabine and docetaxel any better than just gemcitabine alone?"
This is a randomized Phase III trial comparing two treatment regimens in patients with unresectable soft tissue sarcoma. The failure rates observed on both treatment arms (failure defined as progression or death) will be compared to determine which regimen results in the lowest failure rate (Primary objective). As a secondary endpoint, the percentage of patients who are failure-free (failure defined as progression or death) at 3 months and 6 months will be compared between the two arms (Secondary objective).
This trial, sponsored by the North American Sarcoma Study Group of the Connective Tissue Oncology Society, is being done at a number of hospitals around the country and is expected to enroll up to 120 patients.
|United States, New York|
|Memorial Sloan-Kettering Cancer Center|
|New York, New York, United States, 10021|
|Principal Investigator:||Robert Maki, MD, PhD||Memorial Sloan-Kettering Cancer Center|