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Chemoembolisation With CPT11 Loaded DC Bead With Cetuximab and 5FU/LV in First Line in Patients With KRAS Wildtype mCRC

NCT01631539 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2014-12-04

No results posted yet for this study

Summary

The purpose of this study is to assess feasibility of chemoembolization with DC Bead loaded with Irinotecan in combination with Cetuximab and 5FU/LV as a first line treatment for wildtype KRAS unresectable liver metastases from colorectal cancer.

Conditions

Interventions

DEVICE

DC Bead™

chemoembolization with DC Bead™ loaded with Irinotecan

DRUG

Cetuximab

400 mg/m² IV at day 1 followed by 250 mg/m² IV weekly

DRUG

5 FU

every 2 weeks IV

DRUG

Irinotecan

every 4 weeks chemoembolization

Sponsors & Collaborators

  • Biocompatibles UK Ltd

    collaborator INDUSTRY

  • Universitaire Ziekenhuizen KU Leuven

    lead OTHER

Principal Investigators

  • Eric Van Cutsem, MD PhD · Universitaire Ziekenhuizen KU Leuven

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-09-30
Primary Completion
2014-12-31
Completion
2014-12-31

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Diseases

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 NCT01631539 on ClinicalTrials.gov