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Chemoembolization, Irinotecan Bead, Second Line Chemotherapy Treatment of Unresectable Metastatic Colorectal Cancer

NCT00816777 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 4

Last updated 2018-09-07

Study results available
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Summary

The primary objective of this study is to evaluate the safety and efficacy of Irinotecan Bead in combination with intravenous chemotherapy versus intravenous chemotherapy alone in the treatment of unresectable liver metastases in patients with colorectal cancer. The results of this study are intended to be used in support of a PMA application for a combination device

Conditions

  • Unresectable Metastatic Colo-rectal Cancer

Interventions

PROCEDURE

Chemoembolization with irinotecan Bead

Intra arterial chemoembolization using Irinotecan Bead 100mg irinotecan per procedure in combination with irinotecan monotherapy 250mg/m2 alternating on a 3 weekly schedule

DRUG

Irinotecan

Irinotecan monotherapy: 250mg/m2 repeated every 3 weeks

Sponsors & Collaborators

  • Biocompatibles UK Ltd

    collaborator INDUSTRY

  • Generic Devices Consulting, Inc.

    lead INDUSTRY

Principal Investigators

  • Wells Messersmith, MD · University of Colorado, Denver

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-12-31
Primary Completion
2011-01-31
Completion
2011-03-31
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

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 NCT00816777 on ClinicalTrials.gov