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

Phase 3

Completed

• Conditions: Liver Cancer
• Interventions: Drug: sorafenib tosylate; Drug: pravastatin sodium

• Registration Number: NCT01075555
• Lead Sponsor: Federation Francophone de Cancerologie Digestive

Brief 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.

Study Timeline

• Study Start: 2010-02
• Study First Submitted: 2010-02-24
• Study First Submitted QC: 2010-02-24
• Study First Posted: 2010-02-25
• Primary Completion: 2015-09
• Study Completion: 2015-09
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-27
• Last Update Posted: 2020-03-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 323

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
sorafenib	sorafenib tosylate	sorafenib
sorafenib + pravastatine	sorafenib tosylate	sorafenib + pravastatine
sorafenib + pravastatine	pravastatin sodium	sorafenib + pravastatine

Primary Outcome Measures

Name	Time	Method
Overall survival	2014

Secondary Outcome Measures

Name	Time	Method
Time to progression	2014
Progression-free survival	2014

Trial Locations

Locations (1)

Hopital Du Bocage; 🇫🇷 Dijon, France