Phase III Randomized Study Of Sorafenib Plus Doxorubicin Versus Sorafenib In Patients With Advanced Hepatocellular Carcinoma (HCC).

Summary:
The purpose of this study is to compare the effects (good and bad) of the drug sorafenib with the combination of sorafenib plus doxorubicin on you and your advanced primary liver cancer to find out which is better. In this study, you will get either the combination of sorafenib plus doxorubicin or you will receive sorafenib alone. At the present time, sorafenib is approved by the Food and Drug Administration (FDA) for the treatment of hepatocellular carcinoma. Doxorubicin is a marketed drug. It has been used in the treatment of a lot of different cancers, including hepatocellular cancer, but is not specifically FDA approved for hepatocellular cancer. The use of the combination of sorafenib and doxorubicin is not approved by the FDA for hepatocellular carcinoma.

Subjects eligible for this study will receive 1 of 2 treatments:

ARM A:  Sorafenib + Doxorubicin  

                                    OR

ARM B:  Sorafenib

Eligibility and Treatment Plan:

1. Subjects must have hepatocellular carcinoma that cannot be removed by surgery.
2. Subjects must be at least 18 years old.
3. Subjects may NOT have been previously treated with sorafenib.