Sunitinib in Treating Patients With Liver Cancer That Cannot Be Removed by Surgery

DISEASE CHARACTERISTICS:

Inclusion criteria:

* Histologically, cytologically, or radiologically confirmed hepatocellular carcinoma (HCC) meeting 1 of the following criteria:

  * Localized, surgically unresectable disease

    * Candidates for radical surgery for locally advanced disease are excluded
  * Metastatic disease
* Measurable disease, defined as ≥ 1 lesion, outside of pretreated areas, that can be measured in ≥ 1 dimension as ≥ 10 mm by spiral or multi-slice CT scan or MRI
* Child-Pugh class A or mildly decompensated Child-Pugh class B liver dysfunction

Exclusion criteria:

* Clinical ascites of any grade
* Clinical symptoms or history of CNS metastases or leptomeningeal disease
* Known fibrolamellar HCC or mixed cholangiocarcinoma and HCC

PATIENT CHARACTERISTICS:

Inclusion criteria:

* WHO performance status 0-1
* Hemoglobin ≥ 9.0 g/dL
* Absolute neutrophil count ≥ 1,500/mm³
* Platelet count ≥ 75,000/mm³
* Bilirubin ≤ 2 times upper limit of normal (ULN)
* ALT ≤ 7 times ULN
* Albumin ≥ 2.5 g/dL
* Creatinine clearance ≥ 40 mL/min
* Quick test ≥ 50% (adequate coagulation)
* Urine dipstick for proteinuria \< 2+ OR ≤ 1 g of protein in 24-hour urine collection
* Negative pregnancy test
* Fertile patients must use effective contraception during and for 12 months after completion of study therapy

Exclusion criteria:

* Pregnant or nursing
* Encephalopathy
* Malignancy within the past 5 years except for adequately treated cervical carcinoma in situ or localized nonmelanoma skin cancer
* Hemorrhagic or thrombotic cerebrovascular event in the past 12 months
* Documented variceal hemorrhage within the past 3 months
* History or presence of clinically significant acute or unstable cardiovascular, cerebrovascular, renal, gastrointestinal, pulmonary, immunological (except for the presence of hepatitis B virus, hepatitis C virus, or cirrhosis), endocrine, or central nervous system disorders
* Known HIV infection
* Active infection requiring IV antibiotics
* Arterial hypertension ≥ 150/100 mm Hg, despite therapy
* Ongoing cardiac dysrhythmias ≥ grade 2
* Atrial fibrillation of any grade
* Prolongation of QTc \> 500 msec in screening ECG or history of familial long QT syndrome
* Inability to take oral medications
* Psychiatric disorder precluding understanding of information of study-related topics, giving informed consent, or interfering with compliance for oral drug intake

PRIOR CONCURRENT THERAPY:

Inclusion criteria:

* At least 4 weeks since prior surgery or liver-directed therapy (e.g., transarterial embolization/chemoembolization \[limited to 5 treatments\], radiofrequency ablation, cryoablation, radiotherapy, or percutaneous ethanol injection)

  * Previously treated lesions must remain separate from those to be measured in the present study
* Low-dose anticoagulants for maintenance of patency of central venous access or prevention of deep vein thrombosis allowed

Exclusion criteria:

* Prior systemic anticancer treatment for hepatocellular carcinoma
* Prior organ transplantation
* Treatment in a clinical study within the past 30 days
* Concurrent full-dose anticoagulant or requirement for anticoagulant therapy
* Concurrent experimental drugs or other anticancer therapy
* Concurrent use or anticipated need for CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, voriconazole, erythromycin, clarithromycin, and protease inhibitors)
* Concurrent CYP3A4 inducers (e.g., carbamazepine, continuous treatment with dexamethasone \[\> 2 mg/day for \> 7 days\], phenobarbital, phenytoin, rifampicin, and St John's wort)

  * Concurrent antacids allowed provided they are administered \> 1 hour before or \> 1 hour after study drug
* Concurrent elective major surgery
* Concurrent radiotherapy

  * Concurrent analgesic radiotherapy of nontarget lesions allowed