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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

February 16, 2006
July 19, 2011
November 2005
April 2011   (final data collection date for primary outcome measure)
safety
Not Provided
Complete list of historical versions of study NCT00293397 on ClinicalTrials.gov Archive Site
efficacy
Not Provided
Not Provided
Not Provided
 
Chemoembolization Using Doxorubicin in Treating Patients With Liver Cancer That Cannot Be Removed By Surgery
Treatment of Patients With Hepatocellular Carcinoma Using Drug-Eluting Bead Embolization

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.

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.

Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Liver Cancer
Device: doxorubicin hydrochloride
Doxorubicin eluting beads
Not Provided
Reyes DK, Vossen JA, Kamel IR, Azad NS, Wahlin TA, Torbenson MS, Choti MA, Geschwind JF. Single-center phase II trial of transarterial chemoembolization with drug-eluting beads for patients with unresectable hepatocellular carcinoma: initial experience in the United States. Cancer J. 2009 Nov-Dec;15(6):526-32. doi: 10.1097/PPO.0b013e3181c5214b.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
Not Provided
April 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00293397
CDR0000456493, P30CA006973, JHOC-J0516, HOC-05042805
Not Provided
Jeff Geschwind, MD, The Johns Hopkins Medical Institutions
Sidney Kimmel Comprehensive Cancer Center
National Cancer Institute (NCI)
Study Chair: Jeffrey F. Geschwind, MD Sidney Kimmel Comprehensive Cancer Center
Sidney Kimmel Comprehensive Cancer Center
July 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP