Clinical Study Examining the Safety and Efficacy of Doxorubicin Drug Eluting Microspheres Transarterial Embolization in the Setting of Hepatocellular Carcinoma (HCC)
March 14, 2014 updated by: University of British Columbia
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
24
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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British Columbia
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Vancouver, British Columbia, Canada
- Vancouver General Hospital
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
15 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients diagnosed with surgically resectable hepatocellular carcinoma (HCC)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 50mg dose loading per vial of doxorubicin
|
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:
|
|
Experimental: 75mg dose loading per vial of doxorubicin
|
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:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
|---|
|
Histopathological correlation with surgically resected tumor
|
Secondary Outcome Measures
Outcome Measure |
|---|
|
Dose limiting toxicities
|
|
serum doxorubicin release patter
|
|
maximum tolerated dose
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2010
Primary Completion (Actual)
January 1, 2012
Study Completion (Actual)
January 1, 2012
Study Registration Dates
First Submitted
May 3, 2010
First Submitted That Met QC Criteria
May 4, 2010
First Posted (Estimate)
May 5, 2010
Study Record Updates
Last Update Posted (Estimate)
March 17, 2014
Last Update Submitted That Met QC Criteria
March 14, 2014
Last Verified
March 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Adenocarcinoma
- Neoplasms, Glandular and Epithelial
- Digestive System Neoplasms
- Liver Diseases
- Liver Neoplasms
- Carcinoma
- Carcinoma, Hepatocellular
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Topoisomerase II Inhibitors
- Topoisomerase Inhibitors
- Antibiotics, Antineoplastic
- Doxorubicin
Other Study ID Numbers
- H08-02833
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