NCT00125034

Oxaliplatin and Cetuximab in First-line Treatment of Metastatic Colorectal Cancer (mCRC)

Open, Randomized, Controlled, Multicenter Phase II Study Comparing 5-FU/FA Plus Oxaliplatin (FOLFOX-4) Plus Cetuximab Versus 5-FU/FA Plus Oxaliplatin (FOLFOX-4) as First-line Treatment for Epidermal Growth Factor Receptor-expressing Metastatic Colorectal Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 344 (actual)
• Sponsor: Merck KGaA, Darmstadt, Germany · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is an open label, randomized, controlled, multicenter phase II study comparing 5-FU/FA + oxaliplatin (FOLFOX-4) + cetuximab versus 5-FU/FA + oxaliplatin as first-line treatment for epidermal growth factor receptor (EGFR)-expressing mCRC.

Conditions

• Neoplasm Metastasis
• Colorectal Cancer

Interventions

Type	Name	Description
BIOLOGICAL	Cetuximab	Cetuximab will always be administered first, followed by oxaliplatin at least 1 hour later. Following completion of the oxaliplatin infusion or simultaneously with oxaliplatin folinic acid (FA) will be administered (at a dose of 200 mg/m\^2, infused over 120 minutes, on day 1 and day 2, every two weeks) and then 5-Fluorouracil (5-FU) (as a bolus of 400 mg/m\^2/day intravenously (IV) over 2-4 minutes followed by 600 mg/m\^2/day infused over 22-hour, on day 1 and day 2, every two weeks). Until progression or unacceptable toxicity develops
DRUG	Oxaliplatin	Oxaliplatin will always be administered first or simultaneously with FA (at a dose of 200 mg/m\^2, infused over 120 minutes, on day 1 and day 2, every two weeks) and then 5-FU (as a bolus of 400 mg/m\^2/day IV over 2-4 minutes followed by 600 mg/m\^2/day infused over 22-hour, on day 1 and day 2, every two weeks). Until progression or unacceptable toxicity develops

Timeline

• Start date: 2005-07-01
• Primary completion: 2007-03-01
• Completion: 2010-11-01
• First posted: 2005-07-29
• Last updated: 2014-08-07
• Results posted: 2011-10-04

Locations

78 sites across 13 countries: Austria, Belgium, France, Germany, Greece, Israel, Italy, Poland, Portugal, Romania, Russia, Spain, Ukraine