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Liver CancerPhase 2NCT00941967

Sorafenib With or Without Gemcitabine and Oxaliplatin in Treating Patients With Locally Advanced, Unresectable, or Metastatic Liver Cancer

A Phase 2 study testing gemcitabine hydrochloride, oxaliplatin and sorafenib tosylate in people with Liver Cancer, run by Institut du Cancer de Montpellier - Val d'Aurelle at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

RATIONALE: Sorafenib tosylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Drugs used in chemotherapy, such as gemcitabine hydrochloride and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the… 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?
gemcitabine hydrochloride, oxaliplatin and sorafenib tosylate
Could I receive a placebo?
No, everyone receives an active treatment
How many people
78 participants
Where
1 siteFrance
Study dates
Dec 2008to Dec 2012
Phase
Phase 2
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:

  • Histologically or cytologically confirmed hepatocellular carcinoma not amenable to liver transplantation
  • Locally advanced, unresectable, or metastatic disease
  • At least 1 lesion accurately measured in ≥ 1 dimension according to RECIST criteria AND has not been previously treated with local therapy (e.g., intra-arterial chemoembolization, radiofrequency ablation, percutaneous ethanol injection, or cryoablation)
  • No presence of bone metastasis only
  • No known brain metastasis

PATIENT CHARACTERISTICS:

  • WHO performance status 0-1
  • Life expectancy > 12 weeks
  • ANC > 1,500/mm^3
  • WBC > 3,000/mm^3
  • Platelet count ≥ 90,000/mm^3
  • Hemoglobin > 10 g/dL
  • Total protein ≥ 40%
  • ALT or AST ≤ 1.5 times upper limit of normal (ULN)
  • Total bilirubin ≤ 1.5 times ULN
  • Amylase and lipase < 1.5 times ULN
  • Creatinine < 1.5 times ULN
  • Creatinine clearance ≥ 60 mL/min
  • Albumin ≥ 2.8 mg/dL
  • INR ≤ 2.3
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during study and for up to 4 months for females and 6 months for males after completion of study treatment
  • CLIP score 0-3
  • No Child Pugh score B or C cirrhosis
  • No known HIV positivity
  • No other prior malignancy, except adequately treated or curative basal cell skin cancer or carcinoma in situ of the cervix
  • No known or suspected allergy to the investigational agent or any agent given in association with this study
  • No cardiovascular disease, including any of the following:
  • Cardiac arrhythmia requiring antiarrhythmic therapy, except beta-blockers or digoxin for chronic atrial fibrillation
  • Active coronary artery disease or ischemia
  • Myocardial infarction within the past 6 months
  • NYHA class II-IV congestive heart failure
  • No uncontrolled hypertension
  • No severe active bacterial or fungal infection > CTCAE v3.0 grade 2
  • No peripheral neuropathy ≥ grade 2
  • No condition that could affect the absorption of study drug, including any of the following:
  • Malabsorption syndrome
  • Disease significantly affecting gastrointestinal function
  • Bowel obstruction or sub-obstruction
  • No dysphagia or inability to swallow tablets
  • No history of seizures requiring long-term antiepileptic treatment
  • No unstable condition that would jeopardize safety or compliance with study including any of the following :
  • Medical, psychological, or social conditions
  • Substance abuse
  • Legal incapacity or limited legal capacity
  • No psychological, familial, social, or geographic reasons that would preclude clinical follow-up
  • Must be registered in a social security program

PRIOR CONCURRENT THERAPY:

  • No prior organ transplantation with immunosuppressive treatment
  • No prior systemic chemotherapy or systemic antiangiogenic treatment for hepatocellular carcinoma
  • No prior major resection of the stomach or proximal small bowel
  • Prior anticoagulation therapy (e.g., warfarin or heparin) allowed with INR parameters within normal limit range
  • At least 4 weeks since prior local therapy to lesions and treated lesions may not be selected as target lesions
  • No concurrent or prior long-term treatment with CYP3A4 inducers (e.g., rifampin, hypericum perforatum, phenytoin, carbamazepine, phenobarbital, and dexamethasone)
  • No concurrent antitumoral treatment, including tamoxifen, interferon, or somatostatin analogues
  • No other concurrent experimental drugs or anticancer therapy

Trial locations and contacts

1 site in 1 country.

France1 site

  • Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle

    Montpellier, 34295

Other trials in France

About this study

Official title: Randomized Phase II Trial Assessing the Combination of Nexavar® (Sorafenib), and Gemcitabine/Oxaliplatin in Patients Treated for Advanced (Unresectable/Metastatic) Hepatocellular Carcinoma.

RATIONALE: Sorafenib tosylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Drugs used in chemotherapy, such as gemcitabine hydrochloride and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether sorafenib tosylate is more effective when given with or without gemcitabine hydrochloride and oxaliplatin in treating patients with liver cancer.

PURPOSE: This randomized phase II trial is studying sorafenib tosylate to see how well it works when given with or without gemcitabine hydrochloride and oxaliplatin in treating patients with locally advanced, unresectable, or metastatic liver cancer.

Read the detailed description

OBJECTIVES:

Primary

  • Assess progression-free survival (RECIST) in patients with locally advanced, unresectable or metastatic hepatocellular carcinoma treated with sorafenib tosylate with vs without gemcitabine hydrochloride and oxaliplatin.

Secondary

  • Evaluate the tolerability of these regimens in these patients.
  • Determine the objective response rate (RECIST) in patients treated with these regimens.
  • Assess the overall survival of patients treated with these regimens.
  • Evaluate the pharmacokinetics of sorafenib tosylate.
  • Assess biomarkers (e.g., pERK levels) associated with treatment response.
  • Assess angiogenic response by functional imaging.

OUTLINE: This is a multicenter study. Patients are stratified according to performance status and CLIP score. Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive oral sorafenib tosylate as in arm I. Patients also receive gemcitabine hydrochloride IV over 100 minutes on day 1 and oxaliplatin IV over 2 hours on day 2. Treatment with gemcitabine hydrochloride and oxaliplatin repeats every 14 days for 12 courses in the absence of disease progression or unacceptable toxicity.
  • Arm II: Patients receive oral sorafenib tosylate twice daily on days 1-14. In both arms, courses with sorafenib tosylate repeat every 14 days in the absence of disease progression or unacceptable toxicity.

Blood samples and/ or tumor tissue samples may be collected for further analysis.

After completion of study therapy, patients are followed every 2 months until disease progression and then every 6 months thereafter.

Conditions
Liver Cancer
Being tested
gemcitabine hydrochloride, oxaliplatin, sorafenib tosylate
Keywords
adult primary hepatocellular carcinoma, localized unresectable adult primary liver cancer, recurrent adult primary liver cancer, advanced 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.

Study groups in NCT00941967
Study groupRoleWhat they receive
Arm IExperimentalPatients receive oral sorafenib tosylate as in arm I. Patients also receive gemcitabine hydrochloride IV over 100 minutes on day 1 and oxaliplatin IV over 2 hours on day 2. Treatment with gemcitabine hydrochloride and oxaliplatin repeats every 14 days for 12 courses in the absence of disease progression or unacceptable toxicity.
Receives: Drug: sorafenib tosylate
Arm IIExperimentalPatients receive oral sorafenib tosylate twice daily on days 1-14.
Receives: Drug: gemcitabine hydrochloride; Drug: oxaliplatin; Drug: sorafenib tosylate

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Tumor response according to RECIST criteria

    Measured: 18 months

  2. Progression-free survival

    Measured: 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Jul 2009 (estimated)
  2. Study startDec 2008
  3. Primary completionDec 2010
  4. Study completionDec 2012

Resources

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Enrolment
78 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00941967
Sponsor's protocol ID
CDR0000638394
Other IDs
CLCC-GONEXT-PRODIGE-10, VA 2007/40, INCA-RECF0917, EUDRACT-2008-000123-26
Status last verified
Aug 2017
First submitted
17 Jul 2009
Last updated
10 Jul 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Therasse P, Arbuck SG, Eisenhauer EA, Wanders J, Kaplan RS, Rubinstein L, Verweij J, Van Glabbeke M, van Oosterom AT, Christian MC, Gwyther SG. New guidelines to evaluate the response to treatment in solid tumors. European Organization for Research and Treatment of Cancer, National Cancer Institute of the United States, National Cancer Institute of Canada. J Natl Cancer Inst. 2000 Feb 2;92(3):205-16. doi: 10.1093/jnci/92.3.205.

    PubMed 10655437

  • Blay JY, Bonvalot S, Casali P, Choi H, Debiec-Richter M, Dei Tos AP, Emile JF, Gronchi A, Hogendoorn PC, Joensuu H, Le Cesne A, McClure J, Maurel J, Nupponen N, Ray-Coquard I, Reichardt P, Sciot R, Stroobants S, van Glabbeke M, van Oosterom A, Demetri GD; GIST consensus meeting panelists. Consensus meeting for the management of gastrointestinal stromal tumors. Report of the GIST Consensus Conference of 20-21 March 2004, under the auspices of ESMO. Ann Oncol. 2005 Apr;16(4):566-78. doi: 10.1093/annonc/mdi127.

    PubMed 15781488

  • Blay JY, Landi B, Bonvalot S, Monges G, Ray-Coquard I, Duffaud F, Bui NB, Bugat R, Chayvialle JA, Rougier P, Bouche O, Bonichon F, Lassau N, Vanel D, Nordlinger B, Stoeckle E, Meeus P, Coindre JM, Scoazec JY, Emile JF, Ranchere D, Le Cesne A. [Recommendations for the management of GIST patients]. Bull Cancer. 2005 Oct;92(10):907-18. French.

    PubMed 16266874

  • Lassau N, Lamuraglia M, Leclere J, Rouffiac V. [Functional and early evaluation of treatments in oncology: interest of ultrasonographic contrast agents]. J Radiol. 2004 May;85(5 Pt 2):704-12. doi: 10.1016/s0221-0363(04)97651-2. French.

    PubMed 15238871

  • Lassau N, Chami L, Peronneau P. [Current events about echography in 2006: position of the ultrasound functional imaging for the early evaluation of targeted therapeutics]. Bull Cancer. 2006 Dec;93(12):1207-11. French.

    PubMed 17182377

  • Lassau N, Lamuraglia M, Chami L, Leclere J, Bonvalot S, Terrier P, Roche A, Le Cesne A. Gastrointestinal stromal tumors treated with imatinib: monitoring response with contrast-enhanced sonography. AJR Am J Roentgenol. 2006 Nov;187(5):1267-73. doi: 10.2214/AJR.05.1192.

    PubMed 17056915

  • Lamuraglia M, Escudier B, Chami L, Schwartz B, Leclere J, Roche A, Lassau N. To predict progression-free survival and overall survival in metastatic renal cancer treated with sorafenib: pilot study using dynamic contrast-enhanced Doppler ultrasound. Eur J Cancer. 2006 Oct;42(15):2472-9. doi: 10.1016/j.ejca.2006.04.023. Epub 2006 Sep 11.

    PubMed 16965911

  • Escudier B, Lassau N, Angevin E, Soria JC, Chami L, Lamuraglia M, Zafarana E, Landreau V, Schwartz B, Brendel E, Armand JP, Robert C. Phase I trial of sorafenib in combination with IFN alpha-2a in patients with unresectable and/or metastatic renal cell carcinoma or malignant melanoma. Clin Cancer Res. 2007 Mar 15;13(6):1801-9. doi: 10.1158/1078-0432.CCR-06-1432.

    PubMed 17363536

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing gemcitabine hydrochloride, oxaliplatin and sorafenib tosylate in people with Liver Cancer, run by Institut du Cancer de Montpellier - Val d'Aurelle 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 10 Jul 2019. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Tumor response according to RECIST criteria (time frame: 18 months). The study lists 2 primary outcomes in all. 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 NCT00941967, which also lists 8 linked publications.

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 10 Jul 2019.

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