Clinical trial NCT01116635: Clinical Study Examining the Safety and Efficacy of Doxorubicin Drug Eluting Microspheres Transarterial Embolization in the Setting of Hepatocellular Carcinoma (HCC)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Hepatocellular Carcinoma
Keywords: chemoembolization
drug eluting microsphere
hepato
embolotherapy
downstage
Lead sponsor: University of British Columbia
Sponsor class: OTHER
First posted: 2010-05-05
Enrollment: 24
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with surgically resectable hepatocellular carcinoma (HCC)

Primary outcomes:
measure: Histopathological correlation with surgically resected tumor
Secondary outcomes:
measure: Dose limiting toxicities
measure: serum doxorubicin release patter
measure: maximum tolerated dose
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: Vancouver General Hospital
state: British Columbia
Study officials:
affiliation: University of British Columbia
name: Stephen Chung, MD
role: STUDY_DIRECTOR
affiliation: University of British Columbia
name: Jo-Ann Ford, RN
role: STUDY_DIRECTOR
affiliation: University of British Columbia
name: Sharlene Gill, MD
role: STUDY_DIRECTOR
affiliation: University of British Columbia
name: Stephen Ho, MD
role: STUDY_DIRECTOR
affiliation: University of British Columbia
name: David Owen, MD
role: STUDY_DIRECTOR
affiliation: University of British Columbia
name: Charles Scudamore, MD
role: STUDY_DIRECTOR
affiliation: University of British Columbia
name: Ellen Wasan, PhD
role: STUDY_DIRECTOR
affiliation: University of British Columbia
name: Alan Weiss, MD
role: STUDY_DIRECTOR
affiliation: University of British Columbia
name: Eric Yoshida, MD
role: STUDY_DIRECTOR
affiliation: University of British Columbia
name: Sigfried Erb, MD
role: STUDY_DIRECTOR
References:
citation: Klass D, Owen D, Buczkowski A, Chung SW, Scudamore CH, Weiss AA, Yoshida EM, Ford JA, Ho S, Liu DM. The effect of doxorubicin loading on response and toxicity with drug-eluting embolization in resectable hepatoma: a dose escalation study. Anticancer Res. 2014 Jul;34(7):3597-606.