NCT00678535

Erbitux in Combination With Xeloda and Cisplatin in Advanced Esophago-gastric Cancer

Open-label, Randomized, Controlled, Multicenter Phase III Study Investigating Cetuximab in Combination With Capecitabine (Xeloda, X) and Cisplatin (P) Versus XP Alone as First-line Treatment for Subjects With Advanced Gastric Adenocarcinoma Including Adenocarcinoma of the Gastroesophageal Junction

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 904 (actual)
• Sponsor: Merck KGaA, Darmstadt, Germany · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is to demonstrate that addition of cetuximab to 1st-line treatment with capecitabine (Xeloda, X) and cisplatin (P) \[XP\] chemotherapy regimen has a clinically relevant benefit for subjects with advanced gastric adenocarcinoma including gastroesophageal junction (GEJ) adenocarcinoma, in terms of progression free survival (PFS). Secondary objectives are to assess cetuximab plus XP versus XP alone with respect to overall survival, overall tumor response, quality of life (QoL) and safety.

Conditions

• Gastric Cancer

Interventions

Type	Name	Description
DRUG	Cetuximab	Single first dose of cetuximab 400 milligram per square meter (mg/m\^2) will be administered intravenously over 120 minutes followed by weekly intravenous infusion of cetuximab 250 mg/m\^2 over 60 minutes in each 3-week treatment cycle, until documented disease progression, unacceptable toxicity, or withdrawal of consent.
DRUG	Capecitabine	Capecitabine 1000 mg/m\^2 will be administered orally twice daily from evening of Day 1 to morning of Day 15 for every 3-week treatment cycle, until documented disease progression, unacceptable toxicity, or withdrawal of consent.
DRUG	Cisplatin	Cisplatin 80 mg/m\^2 will be administered intravenously with infusion over 1 to 4 hours on Day 1 of each 3-week treatment cycle, until documented disease progression, unacceptable toxicity, or withdrawal of consent.

Timeline

• Start date: 2008-06-01
• Primary completion: 2012-03-01
• Completion: 2013-02-01
• First posted: 2008-05-15
• Last updated: 2014-07-21
• Results posted: 2013-05-16

Locations

130 sites across 25 countries: Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Chile, China, Czechia, France, Germany, Greece, Hong Kong, Hungary, Israel, Italy, Japan, Poland, Portugal, Romania, Russia, South Korea, Spain, Taiwan, United Kingdom