Status:
COMPLETED
Study of Gemcitabine and Vinorelbine in Soft Tissue Sarcomas
Lead Sponsor:
Dana-Farber Cancer Institute
Collaborating Sponsors:
Brigham and Women's Hospital
Massachusetts General Hospital
Conditions:
Sarcoma, Soft Tissue
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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.
Detailed Description
Patients will receive both gemcitabine and vinorelbine once a week for two weeks and then one week with no chemotherapy (1 cycle equals 21 days). Gemcitabine and vinorelbine will be administered on da...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2003
Trial Type :
INTERVENTIONAL
End Date :
June 1 2007
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00134641
Start Date
February 1 2003
End Date
June 1 2007
Last Update
December 21 2007
Active Locations (2)
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1
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
2
Massachusetts General Hospital
Boston, Massachusetts, United States, 02115