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

Phase 2 Completed 302 enrolled Merck KGaA, Darmstadt, Germany

RandomizedParallel-groupOpen-labelTreatment

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)

Timeline

Start: 2007-02
Primary completion: 2009-06
Completion: 2012-05

Publications

Results Douillard JY, Zemelka T, Fountzilas G, Barone C, Schlichting M, Heighway J, Eggleton SP, Srimuninnimit V. FOLFOX4 with cetuximab vs. UFOX with cetuximab as first-line therapy in metastatic colorectal cancer: The randomized phase II FUTURE study. Clin Colorectal Cancer. 2014 Mar;13(1):14-26.e1. doi: 10.1016/j.clcc.2013.11.009. Epub 2013 Nov 16.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Leucovorin	Small molecule	90 mg	Oral
Comparator	Leucovorin	Small molecule	200 mg/m2	Oral
Subject	S-1	Small molecule	250 mg/m2	Oral
Subject	Uracil	Small molecule	560 mg/m2	Oral
Comparator	fluorouracil	Small molecule	400 mg/m2	—
Background	Cetuximab	Monoclonal antibody	250 mg/m2	—
Background	Oxaliplatin	Small molecule	85 mg/m2	—

Indications

No indication recorded.