Pharmacokinetics of Doxorubicin in cTACE of Liver Cancer
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ClinicalTrials.gov Identifier: NCT02753881 |
Recruitment Status :
Completed
First Posted : April 28, 2016
Results First Posted : August 3, 2020
Last Update Posted : August 3, 2020
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Condition or disease | Intervention/treatment | Phase |
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Liver Cancer | Drug: whole liver lobe cTACE doxorubicin Drug: superselective cTACE doxorubicin | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 30 participants |
Allocation: | Non-Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Pharmacokinetics of Doxorubicin in Conventional Transarterial Chemoembolization (cTACE) of Primary and Secondary Liver Cancer |
Actual Study Start Date : | November 2015 |
Actual Primary Completion Date : | December 2019 |
Actual Study Completion Date : | December 2019 |

Arm | Intervention/treatment |
---|---|
Active Comparator: whole liver lobe cTACE doxorubicin
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.
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Drug: whole liver lobe cTACE doxorubicin
Doxorubicin CTACE administered in a whole liver lobe manner. |
Active Comparator: superselective cTACE doxorubicin
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.
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Drug: superselective cTACE doxorubicin
Doxorubicin CTACE administered in a super-selective (close to the tumor) manner. |
- Pharmacokinetics Profile-- Peak of Plasma Concentration (Dose-normalized) [ Time Frame: 0, 5, 10, 20, 40 minutes, 1, 2, 4, 24 hours, and 3-4 weeks post dose ]Peak of plasma concentration (Cmax) of both doxorubicin and doxorubicinol reported for 10 lobar subjects, 10 superselective subjects with Lipiodol distribution to 1 segment, and 10 superselective subjects with Lipiodol distribution to multiple segments after dose normalization.
- Pharmacokinetics Profile-- Peak of Plasma Concentration [ Time Frame: 0, 5, 10, 20, 40 minutes, 1, 2, 4, 24 hours, and 3-4 weeks post dose ]Peak of plasma concentration (Cmax) of doxorubicin and doxorubicinol reported for 10 lobar subjects, 10 superselective subjects with Lipiodol distribution to 1 segment, and 10 superselective subjects with Lipiodol distribution to multiple segments.
- Pharmacokinetics Profile-- Area Under the Concentration Time Curve (Dose Normalized) [ Time Frame: 0, 5, 10, 20, 40 minutes, 1, 2, 4, 24 hours, and 3-4 weeks post dose ]Area under the concentration time curve (AUC) reported for doxorubicin and doxorubicinol reported for 10 lobar subjects, 10 superselective subjects with Lipiodol distribution to 1 segment, and 10 superselective subjects with Lipiodol distribution to multiple segments after dose normalization.
- Pharmacokinetics Profile-- Area Under the Concentration Time Curve [ Time Frame: 0, 5, 10, 20, 40 minutes, 1, 2, 4, 24 hours, and 3-4 weeks post dose ]Area under the concentration time curve (AUC) reported for doxorubicin and doxorubicinol reported for 10 lobar subjects, 10 superselective subjects with Lipiodol distribution to 1 segment, and 10 superselective subjects with Lipiodol distribution to multiple segments.
- Pharmacokinetics Profile-- Time of Maximum Concentration [ Time Frame: 0, 5, 10, 20, 40 minutes, 1, 2, 4, 24 hours, and 3-4 weeks post dose ]Median time of maximum concentration (Tmax) reported for doxorubicin and doxorubicinol reported for 10 lobar subjects, 10 superselective subjects with Lipiodol distribution to 1 segment, and 10 superselective subjects with Lipiodol distribution to multiple segments.
- Number of Participants With Technical Success of cTACE Procedure. [ Time Frame: assessed at baseline (at the time of the cTACE procedure) ]Feasibility/technical success (yes/no) is measured by ability to administer a therapeutic dose, which is determined clinically.
- Assessment and Frequency of Toxicities (Laboratory and Clinical Adverse Events) According to NCI Common Toxicity Criteria for AE (CTCAE) 5.0. [ Time Frame: up to 4 weeks post cTACE ]Adverse events assessed by CTCAE 5.0 and stratified by Lipiodol distribution. 30 patients were reviewed for toxicities.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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)

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02753881
United States, Connecticut | |
Yale University, Department of Diagnostic Radiology | |
New Haven, Connecticut, United States, 06520 |
Principal Investigator: | Todd Schlachter, M.D. | Yale University |
Documents provided by Yale University:
Responsible Party: | Yale University |
ClinicalTrials.gov Identifier: | NCT02753881 |
Other Study ID Numbers: |
1506016008 |
First Posted: | April 28, 2016 Key Record Dates |
Results First Posted: | August 3, 2020 |
Last Update Posted: | August 3, 2020 |
Last Verified: | July 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Product Manufactured in and Exported from the U.S.: | Yes |
Liver Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases Liver Diseases Doxorubicin |
Liposomal doxorubicin Antibiotics, Antineoplastic Antineoplastic Agents Topoisomerase II Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |