Overview

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