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Title   Sorafenib Tosylate With or Without Doxorubicin Hydrochloride in Treating Patients With Locally Advanced or Metastatic Liver Cancer
Description   The purpose of this phase III trial is studying sorafenib tosylate and doxorubicin hydrochloride to see how well they work compared with sorafenib tosylate alone in treating patients with locally advanced or metastatic liver cancer.

Sorafenib tosylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Drugs used in chemotherapy, such as doxorubicin hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.

It is not yet known whether giving sorafenib tosylate together with doxorubicin hydrochloride is more effective than sorafenib tosylate alone in treating liver cancer.
Eligibility Criteria   To be eligible for this study, patients must meet several criteria, including but not limited to the following:

* Patient must be 18 Years and older

* Patient has pathologically or cytologically proven hepatocellular carcinoma (HCC).

* Patient has locally advanced or metastatic disease

* Patients with locally advanced disease must have disease deemed to be unresectable OR not be eligible for transplantation
Principal Investigator   Lakshmi Rajdev, MD
Contact Name   Cheryl Baker, NP
Phone   (718) 405-8508
Contact Email   cbaker@montefiore.org
Post Date   11/17/2009
Protocol Number   2010-349/East
Status   Recruiting
Current Trial Type   Interventional
Montefiore Clinical Trial   No
CHAM Clinical Trial   No