NCT01324076

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as doxorubicin, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Chemoembolization kills tumor cells by carrying drugs directly into the tumor and blocking the blood flow to the tumor. 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. It is not yet known whether transarterial chemoembolization using doxorubicin-eluting beads is more effective when given with or without sorafenib tosylate in treating patients with liver cancer that cannot be removed by surgery. PURPOSE: This randomized phase III trial is studying giving transarterial chemoembolization using doxorubicin-eluting beads and sorafenib tosylate to see how well it works compared with giving transarterial chemoembolization using doxorubicin-eluting beads and a placebo in treating patients with liver cancer that cannot be removed by surgery.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
412

participants targeted

Target at P50-P75 for phase_3

Geographic Reach
1 country

8 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2010

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

March 25, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 28, 2011

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
Last Updated

May 13, 2011

Status Verified

May 1, 2011

Enrollment Period

4 years

First QC Date

March 25, 2011

Last Update Submit

May 12, 2011

Conditions

Liver Cancer

Keywords

adult primary hepatocellular carcinomalocalized unresectable adult primary liver canceradvanced adult primary liver cancer

Outcome Measures

Primary Outcomes (1)

  • Progression-free survival

Secondary Outcomes (5)

  • Overall survival

  • Time to progression

  • Toxicity

  • Disease control (complete or partial response or stable disease)

  • Quality of life

Interventions

doxorubicin-eluting beadsDRUG
sorafenib tosylateDRUG
laboratory biomarker analysisOTHER
pharmacogenomic studiesOTHER
pharmacological studyOTHER
quality-of-life assessmentPROCEDURE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed hepatocellular carcinoma (HCC) OR meets the American Association for the Study of Liver Diseases (AASLD) criteria for diagnosis of HCC * Unresectable disease * Not amenable to liver transplantation * At least one uni-dimensionally measurable lesion according to the RECIST criteria by CT scan or MRI * Child-Pugh A (score ≤ 6) and no Child-Pugh cirrhosis C or B (score ≥ 7) * No ascites refractory to diuretic therapy * No documented occlusion of the hepatic artery or main portal vein * No extrahepatic metastasis or hepatic encephalopathy PATIENT CHARACTERISTICS: * ECOG performance status 0-1 * Life expectancy \> 3 months * Hemoglobin ≥ 9 g/L * Absolute neutrophil count ≥ 1.5 x 10\^9/L * Platelet count ≥ 60,000/μL * Bilirubin ≤ 50 μmol/L * Alkaline phosphatase \< 4 times upper limit of normal (ULN) * AST and ALT \< 5 times ULN * Creatinine ≤ 1.5 times ULN * Amylase and lipase \< 2 times ULN * INR ≤ 1.5 * LVEF ≥ 45% * Able to swallow oral medication * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during study and for 3 months after completion of study treatment * No history of bleeding within the past 4 weeks * No contraindications for hepatic embolization procedures, including portosystemic shunt, hepatofugal blood flow, or known severe atheromatosis * No hypersensitivity to intravenous contrast agents * No active clinically serious infection \> grade 2 (NCI-CTC version 4) * No known history of HIV infection * No history of second malignancy except non-melanotic skin cancer or cervical carcinoma in situ or malignancy treated with curative intent with \> 3 years without relapse * No evidence of severe or uncontrolled disease including any of the following: * Systemic disease * Cardiac arrhythmias (requiring anti-arrhythmic therapy or pacemaker) * Hypertension * NYHA class III or IV congestive cardiac failure * Myocardial infarction within the past 6 months * Laboratory finding that, in the view of the Investigator, makes it undesirable for the patient to participate in the trial * No psychiatric or other disorder likely to impact on informed consent PRIOR CONCURRENT THERAPY: * At least 4 weeks since prior and no concurrent investigational therapy * No prior embolization, systemic therapy, or radiotherapy for HCC * No major surgery within the past 4 weeks * No ablative therapy (radiofrequency ablation or percutaneous ethanol injection) for HCC * Patients with untreated target lesion(s) and ablation occurred \> 6 weeks prior to study entry allowed * No concurrent rifampicin or St. John wort * No concurrent bone marrow transplant or stem cell rescue * No concurrent bevacizumab or drugs that target VEGF or VEGF receptors * No other concurrent anticancer chemotherapy, immunotherapy, hormone therapy, or molecular therapy except bisphosphonates

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

Sponsors & Collaborators

Study Sites (8)

Queen Elizabeth Hospital at University Hospital of Birmingham NHS Trust

Birmingham, England, B15 2TH, United Kingdom

RECRUITING

Bristol Royal Infirmary

Bristol, England, BS2 8HW, United Kingdom

RECRUITING

Aintree University Hospital

Liverpool, England, L9 7AL, United Kingdom

RECRUITING

Royal Free Hospital

London, England, NW3 2QG, United Kingdom

RECRUITING

King's College Hospital

London, England, SE5 9RS, United Kingdom

RECRUITING

Royal Marsden - London

London, England, SW3 6JJ, United Kingdom

RECRUITING

Queen's Medical Centre

Nottingham, England, NG7 2UH, United Kingdom

RECRUITING

Southampton General Hospital

Southampton, England, SO16 6YD, United Kingdom

RECRUITING

MeSH Terms

Conditions

Liver NeoplasmsCarcinoma, Hepatocellular

Interventions

SorafenibPharmacogenomic Testing

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesLiver DiseasesAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Phenylurea CompoundsUreaAmidesOrganic ChemicalsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsNiacinamideNicotinic AcidsAcids, HeterocyclicHeterocyclic CompoundsPyridinesHeterocyclic Compounds, 1-RingGenetic TestingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative TechniquesGenetic TechniquesGenetic ServicesHealth ServicesHealth Care Facilities Workforce and ServicesDiagnostic ServicesPreventive Health Services

Study Officials

  • Tim Meyer, MD, BSc, MRCP, PhD

    Royal Free Hospital NHS Foundation Trust

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 25, 2011

First Posted

March 28, 2011

Study Start

November 1, 2010

Primary Completion

November 1, 2014

Last Updated

May 13, 2011

Record last verified: 2011-05

Locations

GB(8)