CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 70 enrolled
Drug / intervention
Oxaliplatin +4 moredrug
Likely dose
Oxaliplatin 85 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00932438
NCT00932438Phase 2Completed

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

University of Louisville·interventional·Posted Jul 3, 2009·Updated Jun 11, 2021

In Brief

A Phase 2 clinical trial evaluating LC beads loaded with Irinotecan, Oxaliplatin, and 3 other interventions for Colon Cancer With Metastases to the Liver. Completed, enrolled 70 participants across 10 sites in 2 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesArgentina, United States

Timeline

Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedJul 3, 2009
Enrollment StartJun 1, 2009
Primary CompletionDec 1, 2012
TodayJul 2, 2026
Enrollment to primary: 3.5 yearsPosted 17.0 years ago

Interventions

LC beads loaded with Irinotecandevice

Chemoembolization using LC beads loaded with 100mg Irinotecan

Oxaliplatindrug

Oxaliplatin 85 mg/sqm, IV infusion every two weeks

Leucovorindrug

Leucovorin 200 mg/sqm, IV infusion every two weeks

5-Fluorouracildrug

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

Bevacizumabdrug

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