Overview
Study of Gemcitabine and Vinorelbine in Soft Tissue Sarcomas
Status:
Completed
Completed
Trial end date:
2007-06-01
2007-06-01
Target enrollment:
0
0
Participant gender:
All
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 2Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Dana-Farber Cancer InstituteCollaborators:
Brigham and Women's HospitalMassachusetts General Hospital
Treatments:
GemcitabineVinblastine
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