Study of Gemcitabine and Vinorelbine in Soft Tissue Sarcomas
A Phase II Study Evaluating Efficacy of the Combination of Gemcitabine and Vinorelbine in Advanced Soft Tissue Sarcoma
1 other identifier
interventional
40
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Feb 2003
Typical duration for phase_2
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2003
CompletedFirst Submitted
Initial submission to the registry
August 24, 2005
CompletedFirst Posted
Study publicly available on registry
August 25, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2007
CompletedDecember 21, 2007
December 1, 2007
4.3 years
August 24, 2005
December 20, 2007
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To determine the response of the combination of gemcitabine and vinorelbine in patients with metastatic soft tissue sarcoma
Secondary Outcomes (2)
To determine the duration of response and the overall survival of patients with metastatic soft tissue sarcoma being treated with this combination
to evaluate the safety of this combination in this patient population
Interventions
Eligibility Criteria
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.
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Dana-Farber Cancer Institutelead
- Brigham and Women's Hospitalcollaborator
- Massachusetts General Hospitalcollaborator
Study Sites (2)
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115, United States
Massachusetts General Hospital
Boston, Massachusetts, 02115, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Suzanne George, MD
Dana-Farber Cancer Institute
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
August 24, 2005
First Posted
August 25, 2005
Study Start
February 1, 2003
Primary Completion
June 1, 2007
Study Completion
June 1, 2007
Last Updated
December 21, 2007
Record last verified: 2007-12