MedTrace Logo

Study to Evaluate the Efficacy and Safety of FOLFOX-4 Plus Cetuximab Versus UFOX Plus Cetuximab.

NCT00439517 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 302

Last updated 2014-06-27

Study results available
· View outcomes & findings →

Summary

This is an exploratory study to compare activity and safety in 400 patients with previously untreated metastatic carcinoma of the colon treated with UFOX (a combination regimen of UFT® (Tegafur plus Uracil), Oxaliplatin, Folinic Acid) plus Cetuximab or FOLFOX-4 (a combination regimen of 5 Fluorouracil (5-FU), Oxaliplatin and Folinic Acid) plus Cetuximab)

Conditions

  • Previously Untreated Metastatic Colorectal Cancer

Interventions

DRUG

UFOX + Cetuximab

* Cetuximab infusion (400 mg/m\^2 on day 1 of cycle 1 and 250 mg/m\^2 at each subsequent day 1, as well as on days 8, 15 and 22) * Oxaliplatin infusion (85mg/m\^2) on days 1 and 15 (every 2 weeks) * Oral UFT® (250mg/m\^2 tegafur + 560 mg/m\^2 uracil in 3 daily doses rounded to the nearest number of whole capsules) on days 1-21 * Oral Folinic Acid (90 mg in 3 daily divided doses) on days 1-21

DRUG

FOLFOX4 + Cetuximab

* Cetuximab infusion (400 mg/m\^2 on day 1 of cycle 1 and 250 mg/m\^2 at each subsequent day 1, as well as on days 8, 15 and 22) * Oxaliplatin infusion (85 mg/m\^2) on days 1 and 15 (every 2 weeks) * 5-FU bolus + infusions (400 mg/m\^2) on days 1, 2, 15 and 16 * Folinic Acid infusions (200 mg/m\^2) on days 1, 2, 15 and 16

Sponsors & Collaborators

  • Merck KGaA, Darmstadt, Germany

    lead INDUSTRY

Principal Investigators

  • Jean-Yves Douillard, MD PhD · Centre R Gauducheau

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-02-28
Primary Completion
2009-06-30
Completion
2012-05-31

Countries

  • Argentina
  • Australia
  • Austria
  • Belgium
  • Brazil
  • France
  • Germany
  • Greece
  • Hong Kong
  • Israel
  • Italy
  • Mexico
  • Poland
  • Thailand

Study Locations

More Related Trials

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 NCT00439517 on ClinicalTrials.gov