To determine the activity of weekly Docetaxel and Gemcitabine in patients with advanced soft tissue sarcoma previously treated with anthracycline and/or ifosfamide 1. Primary endpoint: response rate 2. Secondary endpoint: progress-free survival, overall survival, safety
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
30
Drug and schedule * Gemcitabine 1000 mg/m2 IV over 10 mg/m2/min (D1, D8) * Docetaxel 35 mg/m2 IV (D1, D8) .. every 21 days Dose modification * Treatment should be delayed if the ANC\<1,500/ mm3, or if the platelet count \<75,000/mm3 on the first day of the next cycle. * Gemcitabine \& docetaxel are omitted on day 8, when ANC is less than 1000/mm3 or platelet count is less than 50,000/mm3; it is reduced by 25% if the ANC is between 1,000 and 1,500/mm3 or the platelet count is between 50,000 and 75,000/mm3 Study design Treatment should consist of at least 2 cycles unless rapid disease progression or unacceptable toxicities occur after one cycle of chemotherapy. Patients with response or no change will receive 2 additional cycles.
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