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.
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
40
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
To determine the response of the combination of gemcitabine and vinorelbine in patients with metastatic soft tissue sarcoma
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
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