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

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.

Conditions

• Hepatocellular Carcinoma

Interventions

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.

Sponsors & Collaborators

• University of British Columbia

  lead OTHER

Principal Investigators

• Stephen Chung, MD · University of British Columbia

• Jo-Ann Ford, RN · University of British Columbia

• Sharlene Gill, MD · University of British Columbia

• Stephen Ho, MD · University of British Columbia

• David Owen, MD · University of British Columbia

• Charles Scudamore, MD · University of British Columbia

• Ellen Wasan, PhD · University of British Columbia

• Alan Weiss, MD · University of British Columbia

• Eric Yoshida, MD · University of British Columbia

• Sigfried Erb, MD · University of British Columbia

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

19 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2010-01-31

Primary Completion

2012-01-31

Completion

2012-01-31

Countries

• Canada

Study Locations