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Pilot Study to Assess the Safety and Pharmacokinetics of 70-150μm Drug Eluting Beads Loaded With Irinotecan (DEBIRI).

NCT02350400 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2017-02-14

No results posted yet for this study

Summary

Background

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:

1. establish safety and toxicity profile of the irinotecan loaded DEBIRI beads
2. establish pharmacokinetics and systemic exposure of irinotecan and its active metabolite, SN-38.

The secondary outcome measurements:

1. the incidence and severity of adverse events, liver function parameters and laboratory abnormalities;
2. response rate,
3. progression free survival
4. overall survival

Clinical Significance

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.

Conditions

  • Colorectal Cancer Metastatic

Interventions

DEVICE

DEBIRI

DEBIRI TACE

Sponsors & Collaborators

  • Singhealth Foundation

    collaborator OTHER_GOV

  • Singapore General Hospital

    lead OTHER

Principal Investigators

  • Kiang Hiong Tay, MBBS FRCR · Singapore General Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-06-30
Primary Completion
2015-12-31
Completion
2016-02-29

Countries

  • Singapore

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02350400 on ClinicalTrials.gov