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

• Status: Completed
• Trial end date: 2015-09-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Sorafenib tosylate and pravastatin may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Sorafenib tosylate may also stop the growth of liver cancer by blocking blood flow to the tumor. It is not yet known whether sorafenib tosylate is more effective when given alone or together with pravastatin in treating patients with liver cancer and cirrhosis.

PURPOSE: This randomized phase III trial is studying sorafenib tosylate given together with pravastatin to see how well it works compared with giving sorafenib tosylate alone in treating patients with liver cancer and cirrhosis.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Federation Francophone de Cancerologie Digestive
• Collaborator: Centre Hospitalier Universitaire Dijon
• Treatments: Niacinamide; Pravastatin; Sorafenib

Criteria

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