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Anti-metabolites

LC Beads loaded with Irinotecan and FOLFOX6 for Colon Cancer (DEBIRI Trial)

Phase 1 & 2
Waitlist Available
Research Sponsored by University of Louisville
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up first treatment through one year post treatment completion
Awards & highlights

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.

Eligible Conditions
  • Colon Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~first treatment through one year post treatment completion
This trial's timeline: 3 weeks for screening, Varies for treatment, and first treatment through one year post treatment completion for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Tumor Response
Secondary study objectives
Number of Serious Adverse Events

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: LC Beads loaded with Irinotecan and FOLFOX6Experimental Treatment5 Interventions
Device: LC Beads loaded with 100mg Irinotecan Drug: Systemic Chemotherapy (FOLFOX6) Oxaliplatin 85 mg/sqm, IV infusion every two weeks Leucovorin 200mg/sqm, IV infusion every two weeks 5-Fluorouracil 2400mg/sqm, IV infusion every two weeks Bevacizumab 5mg/kg given at the discretion of treating physician
Group II: FOLFOX6 and BevacizumabActive Control4 Interventions
Drug: Systemic Chemotherapy (FOLFOX6) Oxaliplatin 85 mg/sqm, IV infusion every two weeks Leucovorin 200mg/sqm, IV infusion every two weeks 5-Fluorouracil 2400mg/sqm, IV infusion every two weeks Bevacizumab 5mg/kg given at the discretion of treating physician
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bevacizumab
FDA approved
LC beads loaded with Irinotecan
2009
Completed Phase 2
~70
Oxaliplatin
FDA approved
Leucovorin
FDA approved
Fluorouracil
FDA approved

Find a Location

Who is running the clinical trial?

University of LouisvilleLead Sponsor
343 Previous Clinical Trials
77,463 Total Patients Enrolled
Biocompatibles UK LtdIndustry Sponsor
24 Previous Clinical Trials
2,459 Total Patients Enrolled
Robert CG Martin, MD, PhDStudy DirectorUniversity of Louisville
2 Previous Clinical Trials
146 Total Patients Enrolled
~4 spots leftby Sep 2025
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