Phase 1
N=30
Pharmacokinetics of Doxorubicin in cTACE of Liver Cancer
Liver Cancer
Bottom Line
View on ClinicalTrials.gov: NCT02753881 ↗Enrolled (actual)
30
Serious AEs
6.7%
Results posted
Aug 2020
Primary outcome: Primary: Pharmacokinetics Profile-- Peak of Plasma Concentration (Dose-normalized) — 2.67; 3.68; 7.11; 0.08 ng/mL/mg — p=.036
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- whole liver lobe cTACE doxorubicin (Drug); superselective cTACE doxorubicin (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Yale University
- Primary completion
- Dec 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pharmacokinetics Profile-- Peak of Plasma Concentration (Dose-normalized) |
2.67; 3.68; 7.11; 0.08; 0.20; 0.34 | .036 sig |
| PRIMARY Pharmacokinetics Profile-- Peak of Plasma Concentration |
83.94; 139.66; 334.35; 3.79; 7.71; 15.87 | — |
| PRIMARY Pharmacokinetics Profile-- Area Under the Concentration Time Curve (Dose Normalized) |
2.87; 4.44; 7.10; 0.63; 1.32; 1.91 | 0.023 sig |
| PRIMARY Pharmacokinetics Profile-- Area Under the Concentration Time Curve |
114.79; 195.80; 307.87; 31.61; 62.27; 79.37 | — |
| PRIMARY Pharmacokinetics Profile-- Time of Maximum Concentration |
0.53; 0.60; 0.33; 1.20; 1.10; 0.38 | — |
| SECONDARY Number of Participants With Technical Success of cTACE Procedure. |
10; 10; 10 | — |
| SECONDARY Assessment and Frequency of Toxicities (Laboratory and Clinical Adverse Events) According to NCI Common Toxicity Criteria for AE (CTCAE) 5.0. |
0; 2; 1; 0; 0; 2 | — |
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).
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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)
Data sourced from ClinicalTrials.gov (NCT02753881). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.