Clinical Trials /

Pharmacokinetics of Doxorubicin in cTACE of Liver Cancer

NCT02753881

Description:

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).

Related Conditions:
  • Hepatocellular Carcinoma
Recruiting Status:

Unknown status

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: Pharmacokinetics of Doxorubicin in cTACE of Liver Cancer
  • Official Title: Pharmacokinetics of Doxorubicin in Conventional Transarterial Chemoembolization (cTACE) of Primary and Secondary Liver Cancer

Clinical Trial IDs

  • ORG STUDY ID: 1506016008
  • NCT ID: NCT02753881

Conditions

  • Liver Cancer

Interventions

DrugSynonymsArms
whole liver lobe cTACE doxorubicinwhole liver lobe cTACE doxorubicin
superselective cTACE doxorubicinsuperselective cTACE doxorubicin

Purpose

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).

Detailed Description

      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). A pharmacokinetics profile (PK profile) will be constructed and will include peak of
      plasma concentration (Cmax), time of maximum concentration (TMax), and area under the
      concentration curve (AUC). This composite measure will be used to compare patients in cTACE
      lobar administration and cTACE superselective administration. In addition, the PK profile
      will be correlated with toxicity, tumor burden, body surface area, and gender. Feasibility
      and safety will also be assessed.
    

Trial Arms

NameTypeDescriptionInterventions
whole liver lobe cTACE doxorubicinActive ComparatorParticipants in this arm are administered 10 cc of chemotherapy, with 50mg doxorubicin and 10 mg of mitomycin-C via cTACE delivered in a lobar (whole liver) manner.
  • whole liver lobe cTACE doxorubicin
superselective cTACE doxorubicinActive ComparatorParticipants in this arm are administered 10 cc of chemotherapy, with 50mg doxorubicin and 10 mg of mitomycin-C via cTACE delivered in a super-selective (close to the tumor) manner.
  • superselective cTACE doxorubicin

Eligibility 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)
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Pharmacokinetics profile-- peak of plasma concentration
Time Frame:up to 4 weeks
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Incidence of feasibility/technical success of the cTACE procedure.
Time Frame:assessed at baseline (at the time of the cTACE procedure)
Safety Issue:
Description:Feasibility/technical success (yes/no) is measured by ability to administer a therapeutic dose, which is determined clinically.
Measure:Frequency of toxicities from cTACE procedure measured using NCI Common Toxicity Criteria v.4.0
Time Frame:up to 4 weeks post cTACE
Safety Issue:
Description:
Measure:Assessment of toxicities by time from cTACE procedure using NCI Common Toxicity Criteria v.4.0
Time Frame:up to 4 weeks post cTACE
Safety Issue:
Description:

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Yale University

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