Clinical Study Examining the Safety and Efficacy of Doxorubicin Drug Eluting Microspheres Transarterial Embolization in the Setting of Hepatocellular Carcinoma (HCC)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of British Columbia
ClinicalTrials.gov Identifier:
NCT01116635
First received: May 3, 2010
Last updated: March 14, 2014
Last verified: March 2014
  Purpose

The study is designed to determine whether loading doxorubicin (a type of chemotherapy), when loaded onto a drug eluting microsphere will result in increased destruction of a tumor. The study will treat patients with surgically resectable liver cancers with varying doses of doxorubicin loaded into microspheres, with a close review of any side effects and chemotherapy concentrations in the bloodstream. The tumors will be surgically removed after at least 1 month, to determine how much the tumor has shrunk, and the amount of tumor destroyed. It is hoped that the study results will determine if this treatment has a role in controlling tumor growth prior to surgical removal.


Condition Intervention Phase
Hepatocellular Carcinoma
Drug: doxorubicin, superabsorbent polymer microspheres, embolotherapy
Phase 1
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: Phase I/II Study Examining Pharmacokinetics, Adverse Events, and Surgically Resected Histopathological Response Utilizing a Dose Escalation Model of Doxorubicin Loaded Drug Eluting Superabsorbent Polymer Microspheres in Surgically Resectable Hepatocellular Carcinoma in Humans

Resource links provided by NLM:


Further study details as provided by University of British Columbia:

Primary Outcome Measures:
  • Histopathological correlation with surgically resected tumor [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Dose limiting toxicities [ Designated as safety issue: No ]
  • serum doxorubicin release patter [ Designated as safety issue: No ]
  • maximum tolerated dose

Enrollment: 24
Study Start Date: January 2010
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 50mg dose loading per vial of doxorubicin Drug: doxorubicin, superabsorbent polymer microspheres, embolotherapy
varying doses of doxorubicin loaded onto SAP during embolization procedure. Pharmacokinetic analysis of elution profile through serum concentrations over 1 month period embolization of surgically resectable HCC with superabsorbent polymer microspheres loaded with doxorubicin from a single treatment. Phase I will follow a modified Fibonacci sequence (with pharmacokinetic analysis of serum doxorubicin) to determine mean tolerated dose (MTD), severe adverse reaction (SAE) and dose limiting toxicities (DLT) when microspheres are loaded with 25mg, 50mg, or 75mg of doxorubicin. Phase II will continue enrollment with the two highest tolerated doses. At least one month after treatment, all patients will undergo imaging and surgical resection of reference tumor, with assessment of degree of necrosis, microsphere distribution, and correlation with concentration of doxorubicin loaded onto microsphere.
Other Names:
  • chemoembolization
  • drug eluting bead
  • drug eluting microsphere
  • superabsorbent microsphere
  • radioembolization
  • bland embolization
Experimental: 75mg dose loading per vial of doxorubicin Drug: doxorubicin, superabsorbent polymer microspheres, embolotherapy
varying doses of doxorubicin loaded onto SAP during embolization procedure. Pharmacokinetic analysis of elution profile through serum concentrations over 1 month period embolization of surgically resectable HCC with superabsorbent polymer microspheres loaded with doxorubicin from a single treatment. Phase I will follow a modified Fibonacci sequence (with pharmacokinetic analysis of serum doxorubicin) to determine mean tolerated dose (MTD), severe adverse reaction (SAE) and dose limiting toxicities (DLT) when microspheres are loaded with 25mg, 50mg, or 75mg of doxorubicin. Phase II will continue enrollment with the two highest tolerated doses. At least one month after treatment, all patients will undergo imaging and surgical resection of reference tumor, with assessment of degree of necrosis, microsphere distribution, and correlation with concentration of doxorubicin loaded onto microsphere.
Other Names:
  • chemoembolization
  • drug eluting bead
  • drug eluting microsphere
  • superabsorbent microsphere
  • radioembolization
  • bland embolization

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patients diagnosed with surgically resectable hepatocellular carcinoma (HCC)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01116635

Locations
Canada, British Columbia
Vancouver General Hospital
Vancouver, British Columbia, Canada
Sponsors and Collaborators
University of British Columbia
Investigators
Study Director: Stephen Chung, MD University of British Columbia
Study Director: Jo-Ann Ford, RN University of British Columbia
Study Director: Sharlene Gill, MD University of British Columbia
Study Director: Stephen Ho, MD University of British Columbia
Study Director: David Owen, MD University of British Columbia
Study Director: Charles Scudamore, MD University of British Columbia
Study Director: Ellen Wasan, PhD University of British Columbia
Study Director: Alan Weiss, MD University of British Columbia
Study Director: Eric Yoshida, MD University of British Columbia
Study Director: Sigfried Erb, MD University of British Columbia
  More Information

No publications provided

Responsible Party: University of British Columbia
ClinicalTrials.gov Identifier: NCT01116635     History of Changes
Other Study ID Numbers: H08-02833
Study First Received: May 3, 2010
Last Updated: March 14, 2014
Health Authority: Canada: Health Canada

Keywords provided by University of British Columbia:
chemoembolization
drug eluting microsphere
hepato
embolotherapy
downstage

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Doxorubicin
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 23, 2014