Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Dana-Farber Cancer Institute
With
Brigham and Women's Hospital
Massachusetts General Hospital
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 day 1 and day 8 of each cycle.
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.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible 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.
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
You may not be 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
