Clinical Trial: Sorafenib and Dacarbazine in Soft Tissue Sarcoma

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Phase II Trial of Sorafenib and Dacarbazine in Soft Tissue Sarcoma

Brief 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.

Detailed Summary:
Sponsor: Memorial Sloan Kettering Cancer Center

Current Primary Outcome: 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)


Original Primary Outcome: 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 ]

Current Secondary Outcome:

Original Secondary Outcome:

  • Time to progression. [ Time Frame: conclusion of the study ]
  • Response Rate by RECIST. [ Time Frame: conclusion of the study ]
  • Response Rate by Choi criteria. [ Time Frame: conclusion of the study ]
  • Evaluate the toxicity of the combination in sarcoma patients [ Time Frame: conclusion of the study ]
  • Overall Survival [ Time Frame: conclusion of the study ]


Information By: Memorial Sloan Kettering Cancer Center

Dates:
Date Received: February 4, 2009
Date Started: February 2009
Date Completion:
Last Updated: October 19, 2015
Last Verified: October 2015