Sorafenib and Dacarbazine in Soft Tissue Sarcoma
|Sarcoma Synovial Sarcoma Leiomyosarcoma Malignant Peripheral Nerve Sheath Tumor||Drug: Sorafenib and Dacarbazine||Phase 2|
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Trial of Sorafenib and Dacarbazine in Soft Tissue Sarcoma|
- Overall Objective Response [ Time Frame: at 18 weeks ]Response and progression will be evaluated in this study using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1)
|Study Start Date:||February 2009|
|Study Completion Date:||November 2013|
|Primary Completion Date:||November 2013 (Final data collection date for primary outcome measure)|
Experimental: Sorafenib and Dacarbazine
This study is an open label, single arm, Simon two stage, phase 2 trial of continuous, daily oral sorafenib, with intravenous dacarbazine administered every three weeks for patients with synovial sarcoma, leiomyosarcoma and malignant peripheral nerve sheath tumor.
Drug: Sorafenib and Dacarbazine
Treatment will be administered on an outpatient basis. Sorafenib is supplied as 200-mg tablets. The starting dose of sorafenib will be 400 mg PO twice daily (every 12 hours) continuously. There is no planned treatment interruption between cycles.
All patients will receive dacarbazine as an open-label dose of 850 mg/m2 by IV infusion over 60 minutes, starting on Week 1 and repeated every 3 weeks until disease progression or intolerance.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00837148
|United States, New York|
|Memorial Sloan-Kettering Cancer Center|
|New York, New York, United States, 10065|
|Principal Investigator:||William Tap, MD||Memorial Sloan Kettering Cancer Center|