Conditions: Sarcoma Leiomyosarcoma Malignant Peripheral Nerve Sheath Tumor Malignant Fibrous Histiocytoma/Undifferentiated Pleomorphic Sarcoma
Keywords: GEMCITABINE GW786034 (PAZOPANIB) TAXOTERE (DOCETAXEL) 11-104
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 5
Healthy volunteers: no

Brief summary:
The purpose of this study is to see the effects, good and/or bad, of the drug combination of gemcitabine, docetaxel and pazopanib on sarcoma. This is a phase Ib-phase II clinical trial. The goal of a phase Ib part of the clinical trial is to confirm a dose of the drugs that is safe. The investigators determine this by closely checking for side effects that the patient may experience.

Detailed description:

Arms:
arm 1: This will be a multicenter single arm phase IB/II trial to evaluate the clinical safety and efficacy of gemcitabine/docetaxel and pazopanib in the neoadjuvant treatment of soft tissue sarcoma.

Interventions: intervention 1: Pazopanib 400 mg QD - Gemcitabine and Docetaxel in Combination
Intervention descriptions: intervention 1: Patients who meet the eligibility criteria above will be treated with the combination therapy of Gemcitabine, Docetaxel, and Pazopanib for two cycles and subsequently re-evaluated for treatment effect. If no progression of the tumor is seen, patients will continue with two more cycles of treatment (total four cycles). Those patients who have progression of disease will proceed directly to surgical resection.

Following completion of neoadjuvant treatment, all patients will have definitive surgical resection. Following recovery from surgery, patients will proceed with adjuvant radiation therapy. Patients will then be followed for 2 years or until January 1st 2015, whichever comes first .

Protocol document: