Sorafenib Tosylate With or Without Pravastatin in Treating Patients With Liver Cancer and Cirrhosis
Condition: Liver Cancer
MeSH terms: Liver Neoplasms
Study type: Interventional
Phase: Phase 3

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.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  To evaluate the effects of sorafenib tosylate and pravastatin versus sorafenib tosylate
           alone on overall survival of patients with hepatocellular carcinoma and Child-Pugh Class
           A cirrhosis.

      Secondary

        -  To evaluate the effect of this regimen on progression-free survival, time to
           progression, time to treatment failure, and quality of life (QLQ-C30 and FACT hep) in
           these patients.

        -  To evaluate the benefit of on-site monitoring versus the centralized data management
           monitoring of these patients.

        -  To characterize polymorphisms to specify the haplotype diversity in these patients.

        -  To test both diagnostic and prognostic signatures by quantitative RT-PCR to determine if
           they can predict response to these regimens.

      OUTLINE: This is a multicenter study. Patients are stratified according to participating
      center, Cancer of the Liver Italian Program (CLIP) score (0 vs 1 vs 2-4), WHO performance
      status (0 vs 1 vs 2), portal vein thrombosis (presence vs absence), and extrahepatic
      metastases (presence vs absence). Patients are randomized to 1 of 2 treatment arms.

        -  Arm I: Patients receive oral sorafenib tosylate twice daily on days 1-28 and oral
           pravastatin once daily on days 1-28. Courses repeat every 4 weeks in the absence of
           disease progression or unacceptable toxicity.

        -  Arm II: Patients receive oral sorafenib tosylate twice daily on days 1-28. Courses
           repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.

      Patients complete quality-of-life questionnaires (QLQ-C30 and FACT) at baseline and then
      every 4 weeks during and after completion of study therapy.

      Blood and tissue samples may be collected for laboratory analysis, including pharmacogenomic
      studies.

      After completion of study therapy, patients are followed up periodically.
    

Intervention name(s): pravastatin sodium; sorafenib tosylate
Intervention type(s): Drug; Drug
Intervention MeSH terms: Sorafenib; Pravastatin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: adult primary hepatocellular carcinoma; localized unresectable adult primary liver cancer; advanced adult primary liver cancer; recurrent adult primary liver cancer