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

NCT01075555 | Completed Phase 3 DMC

• 5 other identifiers: CDR0000666232FFCD-PRODIGE-11FFCD-0803EUDRACT-2009-015785-64EU-21005
• Study Type: interventional
• Target: 323
• Locations: 1 country
• Sites: 1

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.

Conditions

Liver Cancer

Keywords

adult primary hepatocellular carcinoma; localized unresectable adult primary liver cancer; advanced adult primary liver cancer; recurrent adult primary liver cancer

Outcome Measures

Primary Outcomes (1)

• Overall survival

  2014

Secondary Outcomes (2)

• Progression-free survival

  2014

• Time to progression

  2014

Study Arms (2)

sorafenib

ACTIVE COMPARATOR

sorafenib

Drug: sorafenib tosylate

sorafenib + pravastatine

EXPERIMENTAL

sorafenib + pravastatine

Drug: pravastatin sodium; Drug: sorafenib tosylate

Interventions

pravastatin sodium DRUG

sorafenib + pravastatine

sorafenib tosylate DRUG

sorafenib; sorafenib + pravastatine

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Federation Francophone de Cancerologie Digestive: lead
• Centre Hospitalier Universitaire Dijon: collaborator

Study Sites (1)

Hopital Du Bocage

Dijon, 21000, France

Location

Related Publications (1)

• Jouve JL, Lecomte T, Bouche O, Barbier E, Khemissa Akouz F, Riachi G, Nguyen Khac E, Ollivier-Hourmand I, Debette-Gratien M, Faroux R, Villing AL, Vergniol J, Ramee JF, Bronowicki JP, Seitz JF, Legoux JL, Denis J, Manfredi S, Phelip JM; PRODIGE-11 investigators/collaborators. Pravastatin combination with sorafenib does not improve survival in advanced hepatocellular carcinoma. J Hepatol. 2019 Sep;71(3):516-522. doi: 10.1016/j.jhep.2019.04.021. Epub 2019 May 22.

  PMID: 31125576 BACKGROUND

MeSH Terms

Conditions

Liver Neoplasms; Carcinoma, Hepatocellular

Interventions

Pravastatin; Sorafenib

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Liver Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Phenylurea Compounds; Urea; Amides; Benzene Derivatives; Niacinamide; Nicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Study Officials

• Jean-Louis Jouve

  Hopital Du Bocage

  PRINCIPAL INVESTIGATOR

• Jacques Denis, MD

  Hopital Louise Michel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2010
• First Posted: February 25, 2010
• Study Start: February 1, 2010
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: March 30, 2020

Record last verified: 2020-03

Locations

FR (1)