A Randomized Controlled Study of BAY43-9006 in Combination With Doxorubicin Versus Doxorubicin in Patients With Advanced Hepatocellular Carcinoma.

Inclusion Criteria:

- Patients who have a life expectancy of at least 12 weeks

- Patients with advanced HCC (unresectable, and/or metastatic) which has been
histologically or cytologically documented

- Patients must have at least one tumor lesion that meets both of the following
criteria:

- can be accurately measured in at least one dimension according to Response
Evaluation Criteria in Solid Tumors (RECIST)

- has not been previously treated with local therapy

- Patients who have received local therapy except chemoembolization, such as surgery,
radiation therapy, hepatic arterial embolization, radiofrequency ablation,
percutaneous ethanol injection or cryoablation are eligible, provided that they
either have a target lesion which has not been subjected to local therapy and/or the
target lesion(s) within the field of the local therapy has shown an increase of 25%
in the size. Local therapy must be completed at least 4 weeks prior to the baseline
scan

- Patients who have an Eastern Cooperative Oncology Group (ECOG) performance status of
0, 1 or 2

Exclusion Criteria:

- Previous or concurrent cancer that is distinct in primary site or histology from HCC,
EXCEPT cervical carcinoma in situ, treated basal cell carcinoma, and superficial
bladder tumors (Ta, Tis & T1). Any cancer curatively treated > 3 years prior to
entry is permitted

- History of cardiac disease

- Serious myocardial dysfunction

- Active, clinically serious infections

- Known history of Human Immunodeficiency Virus (HIV) infection

- Known Central Nervous System (CNS) tumors including metastatic brain disease

- Patients with clinically significant gastrointestinal bleeding within 30 days prior
to study entry