Sorafenib Tosylate With or Without Pravastatin in Treating Patients With Liver Cancer and Cirrhosis

DISEASE CHARACTERISTICS:

* Diagnosis of hepatocellular carcinoma (HCC), meeting 1 of the following criteria:

  * Histologically confirmed HCC
  * If histological proof can not be obtained (e.g., ascites, coagulation disorders), the diagnosis may be made in cases of cirrhosis according to the 2005 EASL/AASLD criteria by demonstration of a focal hepatic lesion \> 10 mm, meeting 1 of the following criteria:

    * Hypervascular tumor \< 2 cm by 2 dynamic-imaging techniques (e.g., spiral CT scan, MRI scan, or ultrasound with contrast medium)
    * Hypervascular tumor ≥ 2 cm by 1 dynamic-imaging technique (e.g., spiral CT scan, MRI scan, or ultrasound with contrast medium)
* No progressive disease following prior treatment
* Not eligible for curative treatment (i.e., transplantation, resection, or percutaneous destruction) or chemoembolization
* Cancer of the Liver Italian Program (CLIP) prognosis score 0 to 4
* Child-Pugh score A
* No extrahepatic disease threatening the short- or medium-term vital prognosis

PATIENT CHARACTERISTICS:

* WHO performance status 0-2
* Life expectancy \> 12 weeks
* Transaminases ≤ 5 times upper limit of normal (ULN)
* Serum creatinine ≤ 1.5 times ULN
* Not pregnant or nursing
* Fertile patients must use effective contraception during and for 3 months after completion of study therapy
* No other cancerous pathology, except for carcinoma in situ of the cervix, superficial bladder tumors, treated basal cell carcinoma, or any other cancer treated curatively ≥ 3 years ago
* No cardiac insufficiency (NYHA class II or IV congestive heart failure), arterial hypertension, uncontrolled arrhythmia, or myocardial infarction within the past 6 months
* No digestive hemorrhage within the past month
* No major bleeding disorder

PRIOR CONCURRENT THERAPY:

* No prior or other concurrent statins
* No prior sorafenib tosylate