Chemotherapy treatment with docetaxel and gemcitabine is a standard treatment for patients with soft tissue sarcoma. This study is designed to explore whether the addition of tyrosine kinase inhibitor pazopanib enhances the anticancer effect of the chemotherapy drugs. The Phase I component of this study is designed to determine the maximum tolerated dose of pazopanib when given with docetaxel and gemcitabine. The Phase II component is designed to determine the overall response rate of the combination of docetaxel, gemcitabine and pazopanib prior to surgical resection in patients with soft tissue sarcoma.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
6
1500 mg/m\^2 given days 1 and 15 of every 28 day cycle for a total of 4 cycles
50 mg/m\^2 on days 1 and 15 of each 28 day cycle for a total of 4 cycles
Starting dose of 400 mg/day starting 72 hours after docetaxel/gemcitabine administration for 10 days (days 4-13 and 18-27) of each 28 day cycle for a total of 4 cycles. Dose will be increased by 200 mg/day for each cohort until the maximum tolerated dose is identified.
Fletcher Allen Health Care
Burlington, Vermont, United States
Maximum Tolerated Dose
Time frame: 1 cycle (28 days)
Overall response rate
Time frame: 4 cycles (112 days)
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