OBJECTIVES: Primary * Compare the survival of patients with advanced unresectable primary hepatocellular carcinoma treated with intravenous doxorubicin hydrochloride vs doxorubicin hydrochloride chemoembolization. Secondary * Compare the response rate in patients treated with these regimens. * Compare time to progression in patients treated with these regimens. * Compare the toxicity of these regimens in these patients. * Compare the quality of life of patients treated with these regimens. * Compare the health economic implications of these regimens in these patients. OUTLINE: This is a randomized, controlled, multicenter study. Patients are stratified according to participating center, stage of disease, and alpha-fetoprotein levels (< 500 ng/mL vs ≥ 500 ng/mL). Patients are randomized to 1 of 2 treatment arms. * Arm I (control arm): Patients receive doxorubicin hydrochloride IV over 3-5 minutes on day 1. Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. * Arm II (chemoembolization arm): Patients undergo transarterial chemoembolization using DC Bead and doxorubicin hydrochloride. Chemoembolization repeats every 8 weeks for a total of 3 courses in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at baseline and at weeks 10 and 24. Patients are followed at 4 weeks and then every 12 weeks thereafter. Peer Reviewed and Funded or Endorsed by Cancer Research UK PROJECTED ACCRUAL: A total of 280 patients (140 per treatment arm) will be accrued for this study.
DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed hepatocellular carcinoma (HCC) * Advanced, unresectable disease * No clinically significant ascites * No modified Child-Pugh class C liver disease * No main portal vein occlusion/involvement * No extrahepatic tumor of any kind PATIENT CHARACTERISTICS: Age * 18 and over (16 and over for patients residing in Scotland) Performance status * ECOG 0-2 Life expectancy * More than 3 months Hematopoietic * Absolute neutrophil count ≥ 1,500/mm\^3 * Hemoglobin ≥ 8.5 g/dL * Platelet count ≥ 100,000/mm\^3 Hepatic * Bilirubin \< 5.0 mg/dL * Transaminases \< 2.5 times upper limit of normal (ULN) * INR \< 1.5 Renal * Creatinine \< 2 times ULN Cardiovascular * No New York Heart Association class III or IV cardiac disease * No acute angina * No significant peripheral vascular disease * No thrombosis of main portal vein * LVEF ≥ 50% Other * Not pregnant or nursing * Fertile patients must use effective contraception * No other concurrent serious medical condition * No serious infection * No psychological, familial, sociological, or geographical factors that would preclude study compliance * No other malignancy within the past 5 years except carcinoma in situ of the cervix or non-melanoma skin cancer PRIOR CONCURRENT THERAPY: Biologic therapy * No prior biologic therapy for advanced unresectable HCC Chemotherapy * No prior systemic or regional chemotherapy * No prior chemotherapy for advanced unresectable HCC * No other concurrent anticancer chemotherapy Endocrine therapy * No prior hormonal therapy for advanced unresectable HCC Radiotherapy * No prior radiotherapy for advanced unresectable HCC * No other concurrent anticancer radiotherapy Surgery * More than 7 days since prior major surgery * More than 3 days since prior laparoscopy Other * More than 4 weeks since prior investigational agents * More than 6 weeks since prior ablative therapy and must have radiological evidence of progression if ablated site is the only site of disease * No other concurrent investigational agents