Chemoembolization Using Doxorubicin in Treating Patients With Liver Cancer That Cannot Be Removed By Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00293397
Recruitment Status : Completed
First Posted : February 17, 2006
Last Update Posted : July 20, 2011
National Cancer Institute (NCI)
Information provided by:
Sidney Kimmel Comprehensive Cancer Center

Brief Summary:

RATIONALE: Drugs used in chemotherapy, such as doxorubicin, work in different ways to stop the growth of tumor cells, either by killing the cells or stopping them from dividing. Chemoembolization kills tumor cells by blocking the blood flow to the tumor and keeping chemotherapy drugs near the tumor.

PURPOSE: This clinical trial is studying how well chemoembolization using doxorubicin works in treating patients with liver cancer that cannot be removed by surgery.

Condition or disease Intervention/treatment Phase
Liver Cancer Device: doxorubicin hydrochloride Phase 2

Detailed Description:


  • Determine, preliminarily, the feasibility of chemoembolization with GelSpheres™ beads mixed with doxorubicin hydrochloride in patients with unresectable hepatocellular carcinoma.

OUTLINE: This is a pilot study.

Patients undergo catheterization of the hepatic artery followed by chemoembolization comprising an infusion of GelSpheres™ beads mixed with doxorubicin hydrochloride into the target hepatic artery. Patients may receive up to 3 chemoembolization treatments.

After completion of study treatment, patients are followed at 1 month, every 2 months for 1 year, and then every 3 months during year 2.

PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treatment of Patients With Hepatocellular Carcinoma Using Drug-Eluting Bead Embolization
Study Start Date : November 2005
Actual Primary Completion Date : April 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Liver Cancer
U.S. FDA Resources

Intervention Details:
    Device: doxorubicin hydrochloride
    Doxorubicin eluting beads

Primary Outcome Measures :
  1. safety

Secondary Outcome Measures :
  1. efficacy

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Diagnosis of hepatocellular carcinoma (HCC) according to the European Association for the Study of Liver (EASL) disease diagnostic criteria AND the Okuda staging classification

    • No advanced disease, as defined by any of the following:

      • Barcelona Clinic Liver Cancer (BCLC) class C disease, as defined by the following:

        • Vascular invasion, including segmental portal obstruction
        • Extrahepatic spread
        • Cancer-related symptoms (PST of 1-2)
      • BCLC class D disease, as defined by the following:

        • Okuda stage III disease
        • WHO performance status 3 or 4
      • Diffuse HCC, defined as massive ill-defined tumor involvement
      • Child-Pugh Class C
  • Not eligible for radical therapies (e.g., resection, liver transplantation, or percutaneous therapies)
  • No significant liver decompensation

    • Preserved liver function (Child-Pugh class A-B)

      • No ascites (trace ascites allowed)
  • No other active primary tumor
  • Arteries supplying the lesion must be large enough to accept GelSpheres™ beads


  • Bilirubin ≤ 3 mg/dL
  • Albumin > 2.0 g/dL
  • AST and ALT ≤ 5 times the upper limit of normal (ULN)
  • Alkaline phosphatase ≤ 5 times the upper limit of normal (ULN)
  • No active gastrointestinal bleeding
  • No encephalopathy
  • No contraindication to hepatic embolization procedures, as indicated by any of the following:

    • Porto-systemic shunt
    • Hepatofugal blood flow
    • Platelet count < 50,000/mm^3
    • INR ≥ 1.8
    • PTT ≥ 39 seconds
    • Renal failure
    • Severe atheromatosis
  • No contraindication to doxorubicin hydrochloride administration, as indicated by any of the following:

    • Bilirubin > 5 mg/dL
    • WBC < 1,500/mm^3
    • Ejection fraction < 50% by isotopic ventriculography or echocardiography
  • Not pregnant
  • No known allergy to contrast media
  • No intolerance to occlusion procedures
  • No vascular anatomy or bleeding that would preclude catheter placement or emboli injection, as indicated by any of the following:

    • Active or risk of hemorrhage
    • Patent extra-to-intracranial anastomoses or shunts
    • End arteries leading directly to the cranial nerves
    • Feeding arteries smaller than distal branches from which they emerge
    • Collateral vessel pathways that would potentially endanger normal territories during embolization


  • No prior anticancer therapy for HCC

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00293397

United States, Maryland
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21231-2410
Sponsors and Collaborators
Sidney Kimmel Comprehensive Cancer Center
National Cancer Institute (NCI)
Study Chair: Jeffrey F. Geschwind, MD Sidney Kimmel Comprehensive Cancer Center

Publications of Results:
Responsible Party: Jeff Geschwind, MD, The Johns Hopkins Medical Institutions Identifier: NCT00293397     History of Changes
Other Study ID Numbers: CDR0000456493
P30CA006973 ( U.S. NIH Grant/Contract )
First Posted: February 17, 2006    Key Record Dates
Last Update Posted: July 20, 2011
Last Verified: July 2011

Keywords provided by Sidney Kimmel Comprehensive Cancer Center:
adult primary hepatocellular carcinoma
localized unresectable adult primary liver cancer

Additional relevant MeSH terms:
Carcinoma, Hepatocellular
Liver Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Liposomal doxorubicin
Antibiotics, Antineoplastic
Antineoplastic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action