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

May 3, 2010
March 14, 2014
January 2010
January 2012   (final data collection date for primary outcome measure)
Histopathological correlation with surgically resected tumor [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01116635 on ClinicalTrials.gov Archive Site
  • Dose limiting toxicities [ Designated as safety issue: No ]
  • serum doxorubicin release patter [ Designated as safety issue: No ]
  • maximum tolerated dose
Same as current
Not Provided
Not Provided
 
Clinical Study Examining the Safety and Efficacy of Doxorubicin Drug Eluting Microspheres Transarterial Embolization in the Setting of Hepatocellular Carcinoma (HCC)
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

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.

Not Provided
Interventional
Phase 1
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Hepatocellular Carcinoma
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: 50mg dose loading per vial of doxorubicin
    Intervention: Drug: doxorubicin, superabsorbent polymer microspheres, embolotherapy
  • Experimental: 75mg dose loading per vial of doxorubicin
    Intervention: Drug: doxorubicin, superabsorbent polymer microspheres, embolotherapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
January 2012
January 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients diagnosed with surgically resectable hepatocellular carcinoma (HCC)
Both
19 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT01116635
H08-02833
No
University of British Columbia
University of British Columbia
Not Provided
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
University of British Columbia
March 2014

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