Docetaxel, Gemcitabine and Pazopanib as Treatment for Soft Tissue Sarcoma
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.
|Stage III Adult Soft Tissue Sarcoma||Drug: Gemcitabine Drug: Docetaxel Drug: Pazopanib||Phase 1 Phase 2|
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||Phase I/II Study of the Combination of Docetaxel, Gemcitabine and Pazopanib for Neoadjuvant Treatment of Patients With Operable Soft Tissue Sarcoma|
- Maximum Tolerated Dose [ Time Frame: 1 cycle (28 days) ]
- Overall response rate [ Time Frame: 4 cycles (112 days) ]
|Study Start Date:||October 2012|
|Study Completion Date:||April 2015|
|Primary Completion Date:||April 2015 (Final data collection date for primary outcome measure)|
|Experimental: cohort 1||
1500 mg/m^2 given days 1 and 15 of every 28 day cycle for a total of 4 cycles
Other Name: GemzarDrug: Docetaxel
50 mg/m^2 on days 1 and 15 of each 28 day cycle for a total of 4 cycles
Other Name: TaxotereDrug: Pazopanib
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.
Other Name: Votrient
Please refer to this study by its ClinicalTrials.gov identifier: NCT01719302
|United States, Vermont|
|Fletcher Allen Health Care|
|Burlington, Vermont, United States, 05401|