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

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Sidney Kimmel Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00293397
First received: February 16, 2006
Last updated: July 19, 2011
Last verified: July 2011
  Purpose

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 Intervention Phase
Liver Cancer
Device: doxorubicin hydrochloride
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Treatment of Patients With Hepatocellular Carcinoma Using Drug-Eluting Bead Embolization

Resource links provided by NLM:


Further study details as provided by Sidney Kimmel Comprehensive Cancer Center:

Primary Outcome Measures:
  • safety

Secondary Outcome Measures:
  • efficacy

Enrollment: 20
Study Start Date: November 2005
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: doxorubicin hydrochloride
    Doxorubicin eluting beads
Detailed Description:

OBJECTIVES:

  • 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

  • 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

PRIOR CONCURRENT THERAPY:

  • No prior anticancer therapy for HCC
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00293397

Locations
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
Investigators
Study Chair: Jeffrey F. Geschwind, MD Sidney Kimmel Comprehensive Cancer Center
  More Information

Additional Information:
Publications:
Responsible Party: Jeff Geschwind, MD, The Johns Hopkins Medical Institutions
ClinicalTrials.gov Identifier: NCT00293397     History of Changes
Other Study ID Numbers: CDR0000456493, P30CA006973, JHOC-J0516, HOC-05042805
Study First Received: February 16, 2006
Last Updated: July 19, 2011
Health Authority: United States: Federal Government
United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on August 18, 2014