Pharmacokinetics of Doxorubicin in cTACE of Liver Cancer
NCT02753881 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30
Last updated 2020-08-03
Summary
Patients with primary and secondary liver cancer may participate in this study. The purpose is to perform an analysis of the effects of doxorubicin and its metabolite doxorubicinol on the body (doxorubicin pharmacokinetics ) after conventional transarterial chemoembolization (cTACE). cTACE is a procedure in which chemotherapy drugs are injected, followed by an injection of small beads to block the tumor-feeding arteries. Doxorubicin is a chemotherapeutic agent used in the cTACE procedure. This study will examine doxorubicin pharmacokinetics in patients who: 1) receive whole liver cTACE; and 2) receive super-selective CTACE (i.e., delivered in close proximity to the tumor).
Conditions
Interventions
- DRUG
-
whole liver lobe cTACE doxorubicin
Doxorubicin CTACE administered in a whole liver lobe manner.
- DRUG
-
superselective cTACE doxorubicin
Doxorubicin CTACE administered in a super-selective (close to the tumor) manner.
Sponsors & Collaborators
-
Yale University
lead OTHER
Principal Investigators
-
Todd Schlachter, M.D. · Yale University
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2015-11-30
- Primary Completion
- 2019-12-31
- Completion
- 2019-12-31
- FDA Drug
- Yes
Countries
- United States
Study Locations
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