Pharmacokinetics of Doxorubicin in cTACE of Liver Cancer

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Yale University

Status and phase

Completed
Phase 1

Conditions

Liver Cancer

Treatments

Drug: superselective cTACE doxorubicin
Drug: whole liver lobe cTACE doxorubicin

Study type

Interventional

Funder types

Other

Identifiers

NCT02753881
1506016008

Details and patient eligibility

About

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).

Full 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.

Enrollment

30 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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)

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

30 participants in 2 patient groups

whole liver lobe cTACE doxorubicin
Active Comparator group
Description:
Participants 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.
Treatment:
Drug: whole liver lobe cTACE doxorubicin
superselective cTACE doxorubicin
Active Comparator group
Description:
Participants 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.
Treatment:
Drug: superselective cTACE doxorubicin

Trial documents
2

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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