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

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ClinicalTrials.gov Identifier: NCT01075555
Recruitment Status : Completed
First Posted : February 25, 2010
Last Update Posted : May 27, 2016
Sponsor:
Collaborator:
Centre Hospitalier Universitaire Dijon
Information provided by (Responsible Party):
Federation Francophone de Cancerologie Digestive

February 24, 2010
February 25, 2010
May 27, 2016
February 2010
September 2015   (Final data collection date for primary outcome measure)
Overall survival [ Time Frame: 2014 ]
Overall survival
Complete list of historical versions of study NCT01075555 on ClinicalTrials.gov Archive Site
  • Progression-free survival [ Time Frame: 2014 ]
  • Time to progression [ Time Frame: 2014 ]
  • Quality of life [ Time Frame: 2014 ]
  • Progression-free survival
  • Time to progression
  • Quality of life
Not Provided
Not Provided
 
Sorafenib Tosylate With or Without Pravastatin in Treating Patients With Liver Cancer and Cirrhosis
Randomized Phase III Trial Sorafenib-Pravastatin Versus Sorafenib Alone for the Palliative Treatment of Child-Pugh A Hepatocellular Carcinoma

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.

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.

Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Liver Cancer
  • Drug: pravastatin sodium
  • Drug: sorafenib tosylate
  • Active Comparator: sorafenib
    sorafenib
    Intervention: Drug: sorafenib tosylate
  • Experimental: sorafenib + pravastatine
    sorafenib + pravastatine
    Interventions:
    • Drug: pravastatin sodium
    • Drug: sorafenib tosylate
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
323
474
September 2015
September 2015   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 120 Years   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
France
 
 
NCT01075555
CDR0000666232
FFCD-PRODIGE-11
FFCD-0803
EUDRACT-2009-015785-64
EU-21005
Yes
Not Provided
Not Provided
Federation Francophone de Cancerologie Digestive
Federation Francophone de Cancerologie Digestive
Centre Hospitalier Universitaire Dijon
Principal Investigator: Jean-Louis Jouve Hopital Du Bocage
Principal Investigator: Jacques Denis, MD Hopital Louise Michel
Federation Francophone de Cancerologie Digestive
May 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP