Study of Gemcitabine and Vinorelbine in Soft Tissue Sarcomas

• Status: Completed
• Trial end date: 2007-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dana-Farber Cancer Institute
• Collaborators: Brigham and Women's Hospital; Massachusetts General Hospital
• Treatments: Gemcitabine; Vinblastine; Vinorelbine

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