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:
University of British Columbia
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
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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
| Estimated Enrollment: | 60 |
| Study Start Date: | January 2010 |
| Estimated Study Completion Date: | February 2012 |
| Estimated 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:
|
| 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:
|
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: | November 21, 2011 |
| 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 May 22, 2013