Liver CancerPhase 1NCT02753881

Pharmacokinetics of Doxorubicin in cTACE of Liver Cancer

A Phase 1 study testing whole liver lobe cTACE doxorubicin and superselective cTACE doxorubicin in people with Liver Cancer, run by Yale University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Liver Cancer
What is being tested?: whole liver lobe cTACE doxorubicin and superselective cTACE doxorubicin
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 30 participants
Where: 1 siteUnited States
Study dates: Nov 2015to Dec 2019
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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 locations and contacts

1 site in 1 country.

United States1 site

Yale University, Department of Diagnostic Radiology
New Haven, Connecticut, 06520

Other trials in United States

About this study

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

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).

Read the 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.

Conditions: Liver Cancer
Being tested: whole liver lobe cTACE doxorubicin, superselective cTACE doxorubicin
Medical subject headings: Liver Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

whole liver lobe cTACE doxorubicinDrug
Doxorubicin CTACE administered in a whole liver lobe manner.
superselective cTACE doxorubicinDrug
Doxorubicin CTACE administered in a super-selective (close to the tumor) manner.

Study groups in NCT02753881
Study group	Role	What they receive
whole liver lobe cTACE doxorubicin	Active comparator	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. Receives: Drug: whole liver lobe cTACE doxorubicin
superselective cTACE doxorubicin	Active comparator	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. Receives: Drug: superselective cTACE doxorubicin

What is being measured

The primary outcome is the main question the study is designed to answer.

Pharmacokinetics Profile-- Peak of Plasma Concentration (Dose-normalized)
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.
Measured: 0, 5, 10, 20, 40 minutes, 1, 2, 4, 24 hours, and 3-4 weeks post dose
Pharmacokinetics Profile-- Peak of Plasma Concentration
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.
Measured: 0, 5, 10, 20, 40 minutes, 1, 2, 4, 24 hours, and 3-4 weeks post dose
Pharmacokinetics Profile-- Area Under the Concentration Time Curve (Dose Normalized)
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.
Measured: 0, 5, 10, 20, 40 minutes, 1, 2, 4, 24 hours, and 3-4 weeks post dose
Pharmacokinetics Profile-- Area Under the Concentration Time Curve
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.
Measured: 0, 5, 10, 20, 40 minutes, 1, 2, 4, 24 hours, and 3-4 weeks post dose
Pharmacokinetics Profile-- Time of Maximum Concentration
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.
Measured: 0, 5, 10, 20, 40 minutes, 1, 2, 4, 24 hours, and 3-4 weeks post dose

Secondary outcomes (2)

Number of Participants With Technical Success of cTACE Procedure.
Feasibility/technical success (yes/no) is measured by ability to administer a therapeutic dose, which is determined clinically.
Measured: assessed at baseline (at the time of the cTACE procedure)
Assessment and Frequency of Toxicities (Laboratory and Clinical Adverse Events) According to NCI Common Toxicity Criteria for AE (CTCAE) 5.0.
Adverse events assessed by CTCAE 5.0 and stratified by Lipiodol distribution. 30 patients were reviewed for toxicities.
Measured: up to 4 weeks post cTACE

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2015Dec 2019

First posted28 Apr 2016 (estimated)
Study startNov 2015
Primary completionDec 2019
Study completionDec 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Liver CancerStudies of the same condition, open and under way.
More trials run by Yale UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 30 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02753881
Sponsor's protocol ID: 1506016008
Status last verified: Jul 2020
First submitted: 10 Mar 2016
Last updated: 3 Aug 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

Savic LJ, Chapiro J, Funai E, Bousabarah K, Schobert IT, Isufi E, Geschwind JH, Stark S, He P, Rudek MA, Perez Lozada JC, Ayyagari R, Pollak J, Schlachter T. Prospective study of Lipiodol distribution as an imaging marker for doxorubicin pharmacokinetics during conventional transarterial chemoembolization of liver malignancies. Eur Radiol. 2021 May;31(5):3002-3014. doi: 10.1007/s00330-020-07380-w. Epub 2020 Oct 15.
PubMed 33063185

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Liver Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Pharmacokinetics of Doxorubicin in Conventional Transarterial Chemoembolization (cTACE) of Primary and Secondary Liver Cancer
ClinicalTrials.gov ID: NCT02753881
Acronym / sponsor ID: 1506016008
Conditions: Liver Cancer
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 30 participants (actual)
Lead sponsor: Yale UniversityUniversity, hospital or other
Study start: Nov 2015 (actual)
Primary completion: Dec 2019 (actual)
Study completion: Dec 2019 (actual)
First posted: 28 Apr 2016 (estimated)
Results: Posted 3 Aug 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
whole liver lobe cTACE doxorubicin	Active comparator	Drug: whole liver lobe cTACE doxorubicinParticipants 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.
superselective cTACE doxorubicin	Active comparator	Drug: superselective cTACE doxorubicinParticipants 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

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).

Key exclusion criteria (5 listed)

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)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
whole liver lobe cTACE doxorubicinDoxorubicin CTACE administered in a whole liver lobe manner.	Drug	whole liver lobe cTACE doxorubicin
superselective cTACE doxorubicinDoxorubicin CTACE administered in a super-selective (close to the tumor) manner.	Drug	superselective cTACE doxorubicin

Primary outcome

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.

2 secondary outcomes

Number of Participants With Technical Success of cTACE Procedure.
Time frame: assessed at baseline (at the time of the cTACE procedure)
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

Results and safety

Results posted to the registry on 3 Aug 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Superselective cTACE Doxorubicin (One Segment)	10	10
Superselective cTACE (2+ Segments)	10	10
Whole Liver Lobe cTACE Doxorubicin	10	10

Primary outcome: 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. Mean (Standard Deviation). Unit: ng/mL/mg

Measure	Superselective cTACE Doxorubicin (One Segment) n = 10	Superselective cTACE (2+ Segments) n = 10	Whole Liver Lobe cTACE Doxorubicin n = 10
Doxorubicin Cmax normalized dose	2.67 (2.02)	3.68 (4.20)	7.11 (4.24)
Doxorubicinol Cmax normalized for dose	0.08 (0.11)	0.20 (0.22)	0.34 (0.15)

Superselective cTACE Doxorubicin (One Segment) vs Superselective cTACE (2+ Segments) vs Whole Liver Lobe cTACE Doxorubicin: p = .036, Kruskal-Wallis
Superselective cTACE Doxorubicin (One Segment) vs Superselective cTACE (2+ Segments) vs Whole Liver Lobe cTACE Doxorubicin: p = 0.002, Kruskal-Wallis

Population analysed: 6 of 10 lobar, 7 of 10 single segment selective, and 9 of 10 multisegment patients received max 50mg dose of doxorubicin. Dose-normalized concentrations reported for all. Same distributions apply to doxorubicinol results. In addition, for 1 lobar patient and 8 selective patients, doxorubicinol concentrations were below limit of quantification.

Primary outcome: 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. Mean (Standard Deviation). Unit: ng/mL

Measure	Superselective cTACE Doxorubicin (One Segment) n = 10	Superselective cTACE (2+ Segments) n = 10	Whole Liver Lobe cTACE Doxorubicin n = 10
Doxorubicin Cmax	83.94 (75.09)	139.66 (117.73)	334.35 (215.18)
Doxorubicinol Cmax	3.79 (5.52)	7.71 (6.47)	15.87 (7.57)

Primary outcome: 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. Mean (Standard Deviation). Unit: ng*h/mL/mg

Measure	Superselective cTACE Doxorubicin (One Segment) n = 10	Superselective cTACE (2+ Segments) n = 10	Whole Liver Lobe cTACE Doxorubicin n = 10
Doxorubicin dose normalized AUC	2.87 (1.95)	4.44 (4.00)	7.10 (5.58)
Doxorubicinol dose normalized AUC	0.63 (1.16)	1.32 (2.10)	1.91 (2.39)

Superselective cTACE Doxorubicin (One Segment) vs Superselective cTACE (2+ Segments) vs Whole Liver Lobe cTACE Doxorubicin: p = 0.023, Kruskal-Wallis
Superselective cTACE Doxorubicin (One Segment) vs Superselective cTACE (2+ Segments) vs Whole Liver Lobe cTACE Doxorubicin: p = 0.041, Kruskal-Wallis

Primary outcome: 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. Mean (Standard Deviation). Unit: ng*h/mL

Measure	Superselective cTACE Doxorubicin (One Segment) n = 10	Superselective cTACE (2+ Segments) n = 10	Whole Liver Lobe cTACE Doxorubicin n = 10
Doxorubicin AUC	114.79 (109.53)	195.80 (199.40)	307.87 (195.69)
Doxorubicinol AUC	31.61 (57.78)	62.27 (105.66)	79.37 (93.67)

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to 4 weeks post cTACE. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Superselective cTACE Doxorubicin (One Segment)	1 of 10 (10%)	10 of 10 (100%)	1 of 10
Superselective cTACE (2+ Segments)	1 of 10 (10%)	9 of 10 (90%)	0 of 10
Whole Liver Lobe cTACE Doxorubicin	0 of 10 (0%)	10 of 10 (100%)	0 of 10

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 33063185Savic LJ, Chapiro J, Funai E, Bousabarah K, Schobert IT, Isufi E, Geschwind JH, Stark S, He P, Rudek MA, Perez Lozada JC, Ayyagari R, Pollak J, Schlachter T. Prospective study of Lipiodol distribution as an imaging marker for doxorubicin pharmacokinetics during conventional transarterial chemoembolization of liver malignancies. Eur Radiol. 2021 May;31(5):3002-3014. doi: 10.1007/s00330-020-07380-w. Epub 2020 Oct 15.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Todd Schlachter, M.D. principal investigator

Yale University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing whole liver lobe cTACE doxorubicin and superselective cTACE doxorubicin in people with Liver Cancer, run by Yale University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Aug 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02753881, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2020.