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

Merck KGaA (EMD Serono)

Status and phase: Completed; Phase 2

Conditions: Gastric Cancer; Esophageal Cancer

Treatments: Drug: Epirubicin; Drug: Matuzumab; Drug: Capecitabine; Drug: Cisplatin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00215644

2005-000146-36 (EudraCT Number)

EMD 72000-032

Details and patient eligibility

About

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.

Enrollment: 72 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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72 participants in 2 patient groups

Epirubicin, Cisplatin, Capecitabine (ECX)+Matuzumab

Experimental group

Treatment:

Drug: Capecitabine

Drug: Epirubicin

Drug: Cisplatin

Drug: Matuzumab

ECX Only

Active Comparator group

Treatment:

Drug: Capecitabine

Drug: Epirubicin

Drug: Cisplatin