Liver CancerPhase 3NCT01075555
Sorafenib Tosylate With or Without Pravastatin in Treating Patients With Liver Cancer and Cirrhosis
A Phase 3 study testing pravastatin sodium and sorafenib tosylate in people with Liver Cancer, run by Federation Francophone de Cancerologie Digestive at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Liver Cancer
- What is being tested?
- pravastatin sodium and sorafenib tosylate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 323 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2010to Sep 2015
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Liver Cancer
- Being tested
- pravastatin sodium, sorafenib tosylate
- Keywords
- adult primary hepatocellular carcinoma, localized unresectable adult primary liver cancer, advanced adult primary liver cancer, recurrent adult primary liver cancer
- Medical subject headings
- Liver Neoplasms, Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pravastatin sodiumDrug
sorafenib tosylateDrug
| Study group | Role | What they receive |
|---|---|---|
| sorafenib | Active comparator | sorafenib Receives: Drug: sorafenib tosylate |
| sorafenib + pravastatine | Experimental | sorafenib + pravastatine Receives: Drug: pravastatin sodium; Drug: sorafenib tosylate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Measured: 2014
Secondary outcomes (2)
Progression-free survival
Measured: 2014
Time to progression
Measured: 2014
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2010 (estimated)
- Study startFeb 2010
- Primary completionSep 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Liver CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 323 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federation Francophone de Cancerologie Digestive
- Sponsor type
- University, hospital or other
- Collaborators
- Centre Hospitalier Universitaire Dijon
- Responsible party
- Sponsor
- Investigators
- Jean-Louis Jouve, Principal investigator, Hopital Du BocageJacques Denis, MD, Principal investigator, Hopital Louise Michel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01075555
- Sponsor's protocol ID
- CDR0000666232
- Other IDs
- FFCD-PRODIGE-11, FFCD-0803, EUDRACT-2009-015785-64, EU-21005
- Status last verified
- Mar 2020
- First submitted
- 24 Feb 2010
- Last updated
- 30 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 31125576
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Phase III Trial Sorafenib-Pravastatin Versus Sorafenib Alone for the Palliative Treatment of Child-Pugh A Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT01075555
- Acronym / sponsor ID
- CDR0000666232
- Conditions
- Liver Cancer
- Keywords
- adult primary hepatocellular carcinoma, localized unresectable adult primary liver cancer, advanced adult primary liver cancer, recurrent adult primary liver cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 323 participants (actual)
- Lead sponsor
- Federation Francophone de Cancerologie DigestiveUniversity, hospital or other
- Collaborators
- Centre Hospitalier Universitaire Dijon
- Study start
- Feb 2010
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 25 Feb 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| sorafenib | Active comparator | Drug: sorafenib tosylatesorafenib |
| sorafenib + pravastatine | Experimental | Drug: pravastatin sodium, Drug: sorafenib tosylatesorafenib + pravastatine |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pravastatin sodium | Drug | sorafenib + pravastatine |
| sorafenib tosylate | Drug | sorafenib, sorafenib + pravastatine |
Primary outcome
Overall survival
Time frame: 2014
2 secondary outcomes
Progression-free survival
Time frame: 2014
Time to progression
Time frame: 2014
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2020.
- Background: PubMed 31125576Jouve 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean-Louis Jouve principal investigator
Hopital Du Bocage
Jacques Denis, MD principal investigator
Hopital Louise Michel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing pravastatin sodium and sorafenib tosylate in people with Liver Cancer, run by Federation Francophone de Cancerologie Digestive at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time frame: 2014). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01075555, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2020.