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

• Status: Completed
• Trial end date: 2008-08-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck KGaA; Merck KGaA, Darmstadt, Germany
• Treatments: Capecitabine; Epirubicin

Criteria

Inclusion Criteria:

• Histologically confirmed gastric adenocarcinoma or adenocarcinoma of the lower third of the esophagus

• Metastatic disease

• Immunohistological evidence of Epidermal Growth Factor Receptor (EGFR) expression from archived tissues

• Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0-1

• At least 1 measurable lesion (modified World Health Organization criteria)

Exclusion Criteria:

• Previous chemotherapy, unless neo-adjuvant or adjuvant therapy completed greater than (>) 12 months prior to study treatment

• Radiotherapy or major surgery within 4 weeks prior to treatment

• Brain metastases

• Peripheral neuropathy or ototoxicity greater than or equal to (>/=) Grade 2 (National Cancer Institute Common Terminology Criteria for Adverse Events Version 3 [NCICTC V3])

• Abnormal electrocardiogram (ECG)