Pilot Study to Assess the Safety and Pharmacokinetics of 70-150μm Drug Eluting Beads Loaded With Irinotecan (DEBIRI).
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|ClinicalTrials.gov Identifier: NCT02350400|
Recruitment Status : Completed
First Posted : January 29, 2015
Last Update Posted : February 14, 2017
Hepatic metastases of colorectal cancer (MCC) is quite common and is a major source of morbidity and mortality. There has been evidence to show that hepatic arterial chemoembolisation using DC beads (drug eluting beads, 100-300μm) loaded with irinotecan (DEBIRI) showed improved overall survival when compared to systemic therapy (FOLFIRI), but being larger they have their limitations.
New 70-150μm beads are recently available and currently there is limited data concerning its use. Safety of these beads have not been tested in local patients.
Hypothesis / Aim To study the safety and pharmacokinetics of the smaller 70-150μm DEBIRI in a pilot study of 5 patients. The smaller 70-150μm beads will be able to deliver a more consistent and higher dose to tumoral tissue with a smaller systemic dose. Being smaller and less embolic, it will also be better tolerated. Patients will also be genotyped for their UGT1A1*28 and UGT1A1*6 polymorphism status as the latter genotypes are associated with decreased clearance of irinotecan and SN-38 in Asian patients.
Methods Single centre, pilot study, prospectively recruiting 5 patients with unilobar disease, refractory to systemic chemotherapy
The primary endpoints:
- establish safety and toxicity profile of the irinotecan loaded DEBIRI beads
- establish pharmacokinetics and systemic exposure of irinotecan and its active metabolite, SN-38.
The secondary outcome measurements:
- the incidence and severity of adverse events, liver function parameters and laboratory abnormalities;
- response rate,
- progression free survival
- overall survival
This treatment modality has the advantage of directly delivering irinotecan to the liver metastases from colorectal cancer. This local mode of drug delivery may result in a higher intratumoral drug concentration and rapid tumour shrinkage leading to downstaging of the hepatic metastatic lesions. These therapeutic outcomes may also downstage patients to hepatic resection.
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Cancer Metastatic||Device: DEBIRI||Phase 1|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||5 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pilot Study to Assess the Safety and Pharmacokinetics of 70-150μm Drug Eluting Beads Loaded With Irinotecan (DEBIRI) in the Treatment of Hepatic Colorectal Metastases|
|Study Start Date :||June 2014|
|Actual Primary Completion Date :||December 2015|
|Actual Study Completion Date :||February 2016|
For unilobar disease, two treatments will be planned, separated by four weeks. For bilobar disease, there will be four treatments planned, alternating between right and left lobe, separated by 2 weeks duration.
- Establish safety and toxicity profile of the irinotecan loaded DEBIRI beads (number of patients with adverse events according to Health Science Authority's Safety Reporting for Clinical Trials) [ Time Frame: 1 year ]By looking at the number of patients with adverse events according to Health Science Authority's Safety Reporting for Clinical Trials (June 2011)
- Tumour response (measured by mRECIST) [ Time Frame: 6 months ]measured by mRECIST
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): NCT02350400
|Singapore General Hospital|
|Singapore, Singapore, 169608|
|National Cancer Centre Singapore|
|Singapore, Singapore, 169610|
|Principal Investigator:||Kiang Hiong Tay, MBBS FRCR||Singapore General Hospital|