Sorafenib and Dacarbazine in Soft Tissue Sarcoma
The purpose of this study is to find out what effects, good and/or bad, the combination of sorafenib and dacarbazine has on sarcoma. Recurrent sarcoma is difficult to treat. Standard chemotherapy drugs can be toxic, and the length of benefit is usually short. As a result, we need new treatments for sarcoma. Sorafenib is a new type of "targeted" chemotherapy that attacks specific proteins (including "raf" and "VEGF receptor") in cells. We hope that by blocking these proteins we can cause the tumor to shrink. Sorafenib is also known as BAY 43-9006 and by the trade name Nexavar®. The FDA approved sorafenib in December of 2005 to treat patients with kidney cancer and in November of 2007 to treat patients with liver cancer. This drug is not approved by the U.S. Food and Drug Administration (FDA) or any other licensing authority for the treatment of sarcoma and is therefore considered to be experimental in this setting.
Malignant Peripheral Nerve Sheath Tumor
Drug: Sorafenib and Dacarbazine
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Trial of Sorafenib and Dacarbazine in Soft Tissue Sarcoma|
- To determine the clinical benefit response rate (CBR = RECIST Complete Response plus Partial Response plus stable disease at 18 weeks) of selected sarcomas treated with the combination of sorafenib and dacarbazine. [ Time Frame: conclusion of the study ] [ Designated as safety issue: No ]
- Time to progression. [ Time Frame: conclusion of the study ] [ Designated as safety issue: No ]
- Response Rate by RECIST 1.1. [ Time Frame: conclusion of the study ] [ Designated as safety issue: No ]
- Response Rate by Choi criteria. [ Time Frame: conclusion of the study ] [ Designated as safety issue: No ]
- Evaluate the toxicity of the combination in sarcoma patients [ Time Frame: conclusion of the study ] [ Designated as safety issue: Yes ]
- Overall Survival [ Time Frame: conclusion of the study ] [ Designated as safety issue: No ]
|Study Start Date:||February 2009|
|Estimated Study Completion Date:||February 2014|
|Estimated Primary Completion Date:||February 2014 (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.
|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|