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Drug-Eluting Bead, Irinotecan (DEBIRI) Therapy of Liver Metastasis From Colon Cancer With Systemic Fluorouracil, Oxaliplatin, Leucovorin and Bevacizumab

NCT00932438 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2021-06-11

Study results available
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Summary

This is a multicentre, open labeled, controlled phase study designed to assess effectiveness of chemoembolization with LC Beads, both with and without systemic chemotherapy, in the treatment of unresectable liver metastases in patients with colorectal cancer.

Conditions

  • Colon Cancer With Metastases to the Liver

Interventions

DEVICE

LC beads loaded with Irinotecan

Chemoembolization using LC beads loaded with 100mg Irinotecan

DRUG

Oxaliplatin

Oxaliplatin 85 mg/sqm, IV infusion every two weeks

DRUG

Leucovorin

Leucovorin 200 mg/sqm, IV infusion every two weeks

DRUG

5-Fluorouracil

5-Fluorouracil 2400 mg/sqm, IV infusion every 2 week

DRUG

Bevacizumab

Bevacizumab 5 mg/kg given at the discretion of the treating physician

Sponsors & Collaborators

  • Biocompatibles UK Ltd

    collaborator INDUSTRY

  • University of Louisville

    lead OTHER

Principal Investigators

  • Robert CG Martin, MD, PhD · University of Louisville

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-06-30
Primary Completion
2012-12-31
Completion
2012-12-31

Countries

  • United States
  • Argentina

Study Locations

More Related Trials

Entities

Drugs

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 NCT00932438 on ClinicalTrials.gov