Docetaxel, Gemcitabine and Pazopanib as Treatment for Soft Tissue Sarcoma
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|ClinicalTrials.gov Identifier: NCT01719302|
Recruitment Status : Completed
First Posted : November 1, 2012
Last Update Posted : June 16, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Stage III Adult Soft Tissue Sarcoma||Drug: Gemcitabine Drug: Docetaxel Drug: Pazopanib||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||6 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I/II Study of the Combination of Docetaxel, Gemcitabine and Pazopanib for Neoadjuvant Treatment of Patients With Operable Soft Tissue Sarcoma|
|Study Start Date :||October 2012|
|Actual Primary Completion Date :||April 2015|
|Actual Study Completion Date :||April 2015|
|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
- Maximum Tolerated Dose [ Time Frame: 1 cycle (28 days) ]
- Overall response rate [ Time Frame: 4 cycles (112 days) ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01719302
|United States, Vermont|
|Fletcher Allen Health Care|
|Burlington, Vermont, United States, 05401|