At a glance
ClinicalIndex Comparison Record- ✓Histologically or cytologically confirmed leiomyosarcoma, synovial sarcoma, or malignant peripheral nerve sheath tumor (MPNST)
- ✓Metastatic, locally advanced, unresectable, or locally recurrent disease
- ✓Zero to two prior chemotherapy regimens (including neoadjuvant or adjuvant)
- ✓Measurable disease by RECIST 1.1
- ✕Prior therapy with dacarbazine, sorafenib, or other antiangiogenic agents
- ✕Chemotherapy within 3 weeks or radiotherapy within 2 weeks before treatment start
- ✕Known brain metastasis
- ✕Congestive heart failure > NYHA Class II
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Phase II Trial of Sorafenib and Dacarbazine in Soft Tissue Sarcoma
In Brief
A Phase 2 clinical trial evaluating Sorafenib and Dacarbazine for Sarcoma and 3 related conditions. Completed, enrolled 37 participants across 1 site.
Detailed Summary
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.
Study Details
Timeline
Interventions
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.