A Phase II Study Evaluating Efficacy of the Combination of Gemcitabine and Vinorelbine in 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
Patients will remain on this study as long as the disease does not progress or there are no
unacceptable side effects.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To determine the response of the combination of gemcitabine and vinorelbine in patients with metastatic soft tissue sarcoma
Suzanne George, MD
Dana-Farber Cancer Institute
United States: Institutional Review Board
|Dana-Farber Cancer Institute||Boston, Massachusetts 02115|
|Massachusetts General Hospital||Boston, Massachusetts 02114-2617|