Pharmacokinetics of Doxorubicin in cTACE of Liver Cancer
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|ClinicalTrials.gov Identifier: NCT02753881|
Recruitment Status : Unknown
Verified October 2017 by Yale University.
Recruitment status was: Recruiting
First Posted : April 28, 2016
Last Update Posted : February 26, 2018
|Condition or disease||Intervention/treatment||Phase|
|Liver Cancer||Drug: whole liver lobe cTACE doxorubicin Drug: superselective cTACE doxorubicin||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pharmacokinetics of Doxorubicin in Conventional Transarterial Chemoembolization (cTACE) of Primary and Secondary Liver Cancer|
|Study Start Date :||November 2015|
|Estimated Primary Completion Date :||July 2018|
|Estimated Study Completion Date :||August 2018|
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.
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.
Drug: superselective cTACE doxorubicin
Doxorubicin CTACE administered in a super-selective (close to the tumor) manner.
- Pharmacokinetics profile-- peak of plasma concentration [ Time Frame: up to 4 weeks ]
- Pharmacokinetics profile-- time of maximum concentration [ Time Frame: up to 4 weeks ]
- Pharmacokinetics profile-- area under the concentration time curve [ Time Frame: up to 4 weeks ]
- Incidence of feasibility/technical success of the 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.
- Frequency of toxicities from cTACE procedure measured using NCI Common Toxicity Criteria v.4.0 [ Time Frame: up to 4 weeks post cTACE ]
- Assessment of toxicities by time from cTACE procedure using NCI Common Toxicity Criteria v.4.0 [ Time Frame: up to 4 weeks post cTACE ]
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
|Contact: Todd Schlachter, M.D.||203 785 firstname.lastname@example.org|
|Contact: Eliot Funai||203 785 email@example.com|
|United States, Connecticut|
|Yale University, Department of Diagnostic Radiology||Recruiting|
|New Haven, Connecticut, United States, 06520|
|Contact: Todd Schlachter, M.D. 203-785-4747 firstname.lastname@example.org|
|Principal Investigator:||Todd Schlachter, M.D.||Yale University|