Status:
COMPLETED
Matuzumab Treatment With Epirubicin, Cisplatin and Capecitabine (ECX) in Esophago-Gastric Cancer
Lead Sponsor:
Merck KGaA, Darmstadt, Germany
Conditions:
Esophageal Cancer
Gastric Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 ...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
August 31 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 31 2008
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT00215644
Start Date
August 31 2005
End Date
August 31 2008
Last Update
November 2 2018
Active Locations (22)
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1
Research Site
Essen, Germany
2
Research Site
Hamburg, Germany
3
Research Site
Oldenburg, Germany
4
Research Site
Recklinghausen, Germany