Pharmacokinetics of Doxorubicin in cTACE of Liver Cancer
Completed · Phase 1
Conditions studied: Liver Cancer
In brief
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).
Key facts
- Study ID
- NCT02753881
- Run by
- Yale University
- People needed
- 30
- Starts
- 2015-11-01
- Expected to finish
- 2019-12-01
- Last updated by the study team
- 2020-08-03
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Age ≥ 18 years.
- Histologically, cytologically, or radiologically confirmed liver dominant or liver only malignancy.
- Preserved liver function (Child-Pugh A-B class) without significant liver decompensation.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 at study entry.
- Measurable or evaluable disease that will be directly treated with intrahepatic therapy (as defined by Response Evaluation Criteria in Solid Tumors [RECIST] 1.1).
- Suitable for TACE based on blood parameters such as platelet count, bilirubin, and international normalized ratio.
- 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.
You may not qualify if…
- Serum total bilirubin > 3.0 mg/dL
- Creatinine > 2.0 mg/dL
- Platelets < 50000/µL
- Complete portal vein thrombosis with reversal of flow
- Ascites (trace ascites on imaging is acceptable)
Where it is running
- Yale University, Department of Diagnostic Radiology — New Haven, Connecticut, United States
Full record on ClinicalTrials.gov
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