A Research Study to Treat Patients With Advanced Hepatocellular Carcinoma
Carcinoma, Hepatocellular

About this trial
This is an interventional treatment trial for Carcinoma, Hepatocellular focused on measuring Cancer, Liver Cancer, Hepatocellular carcinoma, HCC
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Sorafenib + Doxorubicin
Placebo + Doxorubicin
"Sorafenib + Doxorubicin" -- combination therapy: Sorafenib (Nexavar, BAY43-9006) 200 mg tablets by mouth (orally) twice daily + doxorubicin 60 mg/m2 intravenous infusion every 21 days for 6 cycles (18 weeks)
"Placebo + Doxorubicin" -- monotherapy: Sorafenib (Nexavar, BAY43-9006) matching placebo tablets by mouth (orally) twice daily + doxorubicin 60 mg/m2 intravenous infusion every 21 days for 6 cycles (18 weeks)