Inclusion Criteria

DISEASE CHARACTERISTICS:

- Histologically, cytologically, or serologically* confirmed hepatocellular carcinoma
meeting the following criteria:

- 1-4 lesions

- Involvement of 1 or both liver lobes NOTE: *Alpha-fetoprotein (AFP) > 500 mcg/L
in high-risk patients

- Measurable disease by CT scan or MRI

- Disease does not exceed 50% of the liver parenchyma

- At least 1 lesion ≥ 3 cm in longest diameter

- Tumor burden involves < 50% of the liver

- Refused surgery OR unresectable disease due to any of the following:

- Multifocality

- Advanced cirrhosis

- Comorbid illness

- Candidate for chemoembolization

- No fibrolamellar histology

- No ascites

- No known brain metastases

PATIENT CHARACTERISTICS:

- ECOG performance status 0-2

- Life expectancy ≥ 12 weeks

- WBC ≥ 3,000/mm³

- ANC ≥ 1,500/mm³

- Hemoglobin ≥ 8.5 g/dL (transfusion allowed)

- Platelet count ≥ 100,000/mm³

- Bilirubin ≤ 2 mg/dL

- AST ≤ 5 times upper limit of normal (ULN)

- INR < 1.5

- Creatinine ≤ 2.0 mg/dL OR creatinine clearance ≥ 30 mL/min

- No bleeding diathesis or coagulopathy

- No active congestive heart failure

- No uncontrolled angina

- No myocardial infarction within the past 12 months

- No cardiac arrhythmia

- Ejection fraction ≥ 45% (in patients with known coronary artery disease and in
patients > 50 years of age)

- Child-Pugh class A or B cirrhosis

- No impedance of hepatopedal blood flow (portal vein thrombosis)

- No thrombosis of the main portal vein

- No encephalopathy

- No biliary obstruction

- No variceal bleed within the past 6 months

- No history of allergic reactions attributed to compounds of similar chemical or
biologic composition to sunitinib malate

- No absolute contraindication to doxorubicin, iodinated contrast material,
microfibrillar collage hemostat, or dexamethasone

- No other concurrent uncontrolled illness including, but not limited to, any of the
following:

- Ongoing or active infection

- Psychiatric illness or social situation that would limit compliance with study
requirements

- No other active malignancies within the past year except nonmelanoma skin cancer or
carcinoma in situ

- No significant traumatic injury within the past 4 weeks

- No QTc prolongation (i.e., QTc interval ≥ 500 msec) or other significant ECG
abnormalities

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception during and for 6 months after the
completion of study treatment

PRIOR CONCURRENT THERAPY:

- Recovered from prior therapy

- Prior liver-directed therapy, such as chemoembolization, radiofrequency ablation,
cryoablation, or ethanol injection allowed if the following criteria are met:

- Treated lesion remains inactive by CT scan or MRI and new lesion being embolized
is distinct from the previously treated lesion

- Radiographic progression of previously treated lesion requiring re-embolization

- Prior liver resection allowed

- Prior immunotherapy allowed

- No prior antiangiogenesis therapy

- No prior liver transplantation

- Patients awaiting a cadaveric or orthotopic liver transplantation are eligible
provided they have end-stage liver disease with a priority score of < 20 points

- More than 4 weeks since prior radiotherapy or chemotherapy (6 weeks for nitrosoureas
or mitomycin C)

- More than 4 weeks since prior major surgery or open biopsy

- At least 1 week since prior fine needle biopsy

- No concurrent immunotherapy

- No concurrent radiotherapy

- No concurrent combination antiretroviral therapy for HIV-positive patients

- No concurrent therapeutic doses of coumarin-derivative anticoagulants (e.g.,
warfarin)

- Doses of ≤ 1 mg/day are allowed for prophylaxis of thrombosis as long as INR ≤
1.5

- Both full dose and prophylactic dose low molecular weight heparin allowed as
long as PT INR ≤ 1.5

- No anticipated major surgery during and for 3 months after completion of study
treatment

- No other concurrent investigational agents

- No other concurrent anticancer therapy