Overview

Pharmacokinetics of Doxorubicin in cTACE of Liver Cancer

Status:
Completed
Trial end date:
2019-12-01
Target enrollment:
0
Participant gender:
All
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).
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Yale University
Treatments:
Doxorubicin
Liposomal doxorubicin
Liver Extracts
Criteria
Inclusion Criteria:

1. Age ≥ 18 years.

2. Histologically, cytologically, or radiologically confirmed liver dominant or liver
only malignancy.

3. Preserved liver function (Child-Pugh A-B class) without significant liver
decompensation.

4. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 at study entry.

5. Measurable or evaluable disease that will be directly treated with intrahepatic
therapy (as defined by Response Evaluation Criteria in Solid Tumors [RECIST] 1.1).

6. Suitable for TACE based on blood parameters such as platelet count, bilirubin, and
international normalized ratio.

7. May be enrolled with a history of prior liver directed intra-arterial therapy if
intra-arterial therapy to the target lesion occured > 1 year prior to enrollment date.
Intra-arterial therapy to different targets within 1 year prior to enrollment date
will not exclude subjects.

Exclusion Criteria:

1. Serum total bilirubin > 3.0 mg/dL

2. Creatinine > 2.0 mg/dL

3. Platelets < 50000/µL

4. Complete portal vein thrombosis with reversal of flow

5. Ascites (trace ascites on imaging is acceptable)