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

This study is ongoing, but not recruiting participants.

Sponsor:

Information provided by (Responsible Party):

University of British Columbia

ClinicalTrials.gov Identifier:

NCT01116635

First received: May 3, 2010

Last updated: November 21, 2011

Last verified: November 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

May 3, 2010

Last Updated Date

November 21, 2011

Start Date ^ICMJE

January 2010

Estimated Primary Completion Date

January 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Histopathological correlation with surgically resected tumor [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01116635 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 1
Phase 2

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Hepatocellular Carcinoma

Intervention ^ICMJE

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

Study Arm (s)

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

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

February 2012

Estimated Primary Completion Date

January 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Patients diagnosed with surgically resectable hepatocellular carcinoma (HCC)

Gender

Both

Ages

19 Years and older

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Canada

Administrative Information

NCT Number ^ICMJE

NCT01116635

Other Study ID Numbers ^ICMJE

H08-02833

Has Data Monitoring Committee

Responsible Party

University of British Columbia

Study Sponsor ^ICMJE

University of British Columbia

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

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

Information Provided By

University of British Columbia

Verification Date

November 2011

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

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