NCT00215644

Matuzumab Treatment With Epirubicin, Cisplatin and Capecitabine (ECX) in Esophago-Gastric Cancer

Randomized Phase II Open-Label Controlled Study of EMD 72000 (Matuzumab), in Combination With the Chemotherapy Regimen ECX or the Chemotherapy Regimen ECX Alone as First-line Treatment in Subjects With Metastatic Esophago-Gastric Adenocarcinoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 72 (actual)
• Sponsor: Merck KGaA, Darmstadt, Germany · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to compare the effectiveness and safety of experimental treatment matuzumab and ECX chemotherapy, with ECX chemotherapy. Participants invited to take part have metastatic cancer of the esophagus (gullet) or stomach.

Conditions

• Esophageal Cancer
• Gastric Cancer

Interventions

Type	Name	Description
DRUG	Matuzumab	Participants will receive matuzumab 800 milligrams (mg) intravenously (IV) every week, until disease progression (PD), unacceptable toxicity, death, or consent is withdrawn.
DRUG	Epirubicin	Participants will receive epirubicin 50 milligrams per square meter (mg/m\^2) on Day 1 of 21-day cycle up to a maximum of 8 cycles.
DRUG	Cisplatin	Participants will receive cisplatin 60 mg/m\^2 on Day 1 of 21-day cycle up to a maximum of 8 cycles.
DRUG	Capecitabine	Participants will receive capecitabine 1250 mg/m\^2 daily in a 21-day cycles up to a maximum of 8 cycles.

Timeline

• Start date: 2005-08-31
• Primary completion: 2008-07-31
• Completion: 2008-08-31
• First posted: 2005-09-22
• Last updated: 2018-11-02
• Results posted: 2018-11-02

Locations

22 sites across 4 countries: Germany, Spain, Switzerland, United Kingdom