NCT01719302

Docetaxel, Gemcitabine and Pazopanib as Treatment for Soft Tissue Sarcoma

Phase I/II Study of the Combination of Docetaxel, Gemcitabine and Pazopanib for Neoadjuvant Treatment of Patients With Operable Soft Tissue Sarcoma

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: University of Vermont · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Stage III Adult Soft Tissue Sarcoma

Interventions

Type	Name	Description
DRUG	Gemcitabine	1500 mg/m\^2 given days 1 and 15 of every 28 day cycle for a total of 4 cycles
DRUG	Docetaxel	50 mg/m\^2 on days 1 and 15 of each 28 day cycle for a total of 4 cycles
DRUG	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.

Timeline

• Start date: 2012-10-01
• Primary completion: 2015-04-01
• Completion: 2015-04-01
• First posted: 2012-11-01
• Last updated: 2016-06-16

Locations

1 site across 1 country: United States