Study of Gemcitabine and Vinorelbine in Soft Tissue Sarcomas
NCT ID: NCT00134641
Last Updated: 2007-12-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
40 participants
INTERVENTIONAL
2003-02-28
2007-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Blood tests will be performed on each day chemotherapy is administered. A CT scan will be done after every 2 cycles (approximately every 6 weeks) to determine the effects of the chemotherapy on the sarcoma.
A physical exam will be performed at the start of chemotherapy and at least every three weeks thereafter.
Patients will remain on this study as long as the disease does not progress or there are no unacceptable side effects.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
gemcitabine
vinorelbine
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Brigham and Women's Hospital
OTHER
Massachusetts General Hospital
OTHER
Dana-Farber Cancer Institute
OTHER
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Suzanne George, MD
Role: PRINCIPAL_INVESTIGATOR
Dana-Farber Cancer Institute
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
02-282
Identifier Type: -
Identifier Source: org_study_id