MedTrace Logo

Cetuximab in Neoadjuvant Treatment of Non-Resectable Colorectal Liver Metastases (CELIM)

NCT00153998 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 135

Last updated 2009-02-27

No results posted yet for this study

Summary

General Objectives:

* To test the feasibility of neoadjuvant treatment with cetuximab/chemotherapy followed by liver resection
* To determine the optimal combination (cetuximab/FOLFOX versus cetuximab/FOLFIRI) for further trials in preoperative chemotherapy

Conditions

Interventions

DRUG

Cetuximab

PROCEDURE

Liver resection

DRUG

Cetuximab and FOLFIRI

Cetuximab 400 mg/m² (2.0 h i.v.) (first dose only), followed by: Cetuximab 250 mg/m² (1.0 h i.v.) weekly Irinotecan 180 mg/m² (2.0 h i.v.) all compounds day 1, repeated at day 15 Folinic acid (D,L) 400 mg/m² (2.0 h i.v.) 5-FU 400 mg/m² (bolus i.v.) 5-FU 2400 (-3000) mg/m² (46 h i.v.)

DRUG

Cetuximab and FOLFOX

Cetuximab 400 mg/m² (2.0 h i.v.) (first dose only), followed by: Cetuximab 250 mg/m² (1.0 h i.v.) weekly Oxaliplatin 100 mg/m² (2.0 h i.v.) all compounds day 1, repeated at day 15 Folinic acid (D,L) 400 mg/m² (2.0 h i.v.) 5-FU 400 mg/m² (bolus i.v.) 5-FU 2400 (-3000) mg/m² (46 h i.v.)

Sponsors & Collaborators

  • Technische Universität Dresden

    lead OTHER

Principal Investigators

  • Claus-Henning Köhne, Prof. Dr. · Klinikum Oldenburg GmbH, Dr.-Eden-Str.10; 26133 Oldenburg

  • Gunnar Folprecht, Dr. · University Hospital Dresden, Fetscherstr. 74, 01307 Dresden, Germany

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-11-30
Primary Completion
2008-03-31

Countries

  • Austria
  • Germany

Study Locations

More Related Trials

Entities

Drugs
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 NCT00153998 on ClinicalTrials.gov