Sorafenib Tosylate With or Without Pravastatin in Treating Patients With Liver Cancer and Cirrhosis
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Randomized Phase III Trial Sorafenib-Pravastatin Versus Sorafenib Alone for the Palliative Treatment of Child-Pugh A Hepatocellular Carcinoma|
- Overall survival [ Time Frame: 2014 ] [ Designated as safety issue: No ]
- Progression-free survival [ Time Frame: 2014 ] [ Designated as safety issue: No ]
- Time to progression [ Time Frame: 2014 ] [ Designated as safety issue: No ]
- Quality of life [ Time Frame: 2014 ] [ Designated as safety issue: No ]
|Study Start Date:||February 2010|
|Estimated Study Completion Date:||June 2015|
|Estimated Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
Active Comparator: sorafenib
|Drug: sorafenib tosylate|
Experimental: sorafenib + pravastatine
sorafenib + pravastatine
|Drug: pravastatin sodium Drug: sorafenib tosylate|
- 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.
- 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.
|Hopital Du Bocage|
|Dijon, France, 21000|
|Principal Investigator:||Jean-Louis Jouve||Hopital Du Bocage|
|Principal Investigator:||Jacques Denis, MD||Hopital Louise Michel|