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
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.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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
Robert Maki, MD, PhD
Principal Investigator
Memorial Sloan-Kettering Cancer Center
United States: Institutional Review Board
02-129
NCT00142571
January 2003
September 2007
Name | Location |
---|---|
Memorial Sloan-Kettering Cancer Center | New York, New York 10021 |