Study of Gemcitabine and Vinorelbine in Soft Tissue Sarcomas
Sarcoma, Soft Tissue
About this trial
This is an interventional treatment trial for Sarcoma, Soft Tissue focused on measuring soft tissue sarcoma, metastatic soft tissue sarcoma, gemcitabine, vinorelbine
Eligibility Criteria
Inclusion Criteria: Histologic diagnosis of unresectable or metastatic soft tissue sarcoma Measurable disease outside of a prior irradiated area ECOG performance status 0,1, or 2. 0 or 1 prior regimens for advanced disease. Adequate end organ function, defined as bilirubin < 1.8; SGOT/SGPT < 2.5 x upper limit of normal (ULN); creatinine < 1.5 x ULN. Negative pregnancy test Life expectancy of greater than 3 months Exclusion Criteria: Patient has received any investigational agents within 28 days of first day of study drug dosing Two or more prior regimens for advanced disease Prior gemcitabine or vinorelbine Another primary malignancy Grade III/IV cardia dysfunction Female patients who are pregnant or breast-feeding Severe and/or life-threatening medical disease Known diagnosis of HIV infection Prior chemotherapy within 4 weeks prior to study entry Major surgery within 2 weeks prior to study entry Known hypersensitivity to either gemcitabine or vinorelbine
Sites / Locations
- Dana-Farber Cancer Institute
- Massachusetts General Hospital