Study of Gemcitabine and Vinorelbine in Soft Tissue Sarcomas

Completed · Phase 2

Conditions studied: Sarcoma, Soft Tissue

In brief

The purpose of this study is to determine if the combination of gemcitabine and vinorelbine is effective in treating patients with advanced soft tissue sarcoma.

Key facts

Study ID

NCT00134641

Run by

Dana-Farber Cancer Institute

People needed

40

Starts

2003-02-01

Expected to finish

2007-06-01

Last updated by the study team

2007-12-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Dana-Farber Cancer Institute — Boston, Massachusetts, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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