Metastatic Esophago-gastric adenocarcinoma MedDRA version: 9.1 Level: LLT Classification code 10001150 Term: Adenocarcinoma gastric
Conditions
Sponsors
Merck KGaA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Written informed consent provided prior to any prescreening procedure 2. Male or female, 18 years or older 3. Histologically confirmed gastric adenocarcinoma or adenocarcinoma of the lower third of the esophagus 4. Metastatic disease 5. Normal cardiac function (left ventricular ejection fraction within the institutional normal range) 6. At least 1 measurable lesion according to the modified WHO criteria as defined in Section 7.2.2. 7. Archived tissue available for EGFR testing and immunohistochemical evidence of tumor EGFR (HER-1) expression in the most recent available sample 8. ECOG (Eastern Cooperative Oncology Group) performance status 0-1 9. Life-expectancy > 12 weeks 10. Adequate liver, bone marrow, and renal function, defined as: • Bilirubin 1500 mm3 • Platelets > 100 000/µl • Hemoglobin > 10g/dl • Serum creatinine =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Previous chemotherapy, unless neo- adjuvant or adjuvant therapy completed > 12 months prior to study treatment. Subjects previously treated with anthracyclins must not exceed total cumulative dose described in the treatments section. 2. Radiotherapy or major surgery within the last 4 weeks prior to the start of study treatment 3. Prior treatment with an EGFR signal transduction directed therapy 4. Uncontrolled angina pectoris, heart failure, clinically significant uncontrolled cardiac arrhythmias 5. Clinically significantly abnormal electrocardiogram (ECG) or cardiac history (e.g. subjects with myocardial infarction within the last 6 months) 6. Treatment with non-permitted medication (as specified in Section 6.8). 7. Documented or symptomatic brain metastases and/or central nervous system metastases or leptomeningeal disease. 8. Superior vena cava syndrome contra-indicating hydration 9. Symptomatic peripheral neuropathy NCI-CTCAE grade =2 and/or ototoxicity grade =2, except if due to trauma or mechanical impairment due to tumor mass 10. Known active, uncontrolled infections, uncontrolled severe organ dysfunction or metabolic disorder or any other significant disease which in the investigator’s opinion would exclude the subject from the study 11. Pregnancy (confirmed by ß-HCG) or lactation period 12. Known hypersensitivity to matuzumab or any of the components of ECX (according to the current investigators’ brochure for matuzumab and the relevant product information sheets for epirubicin, cisplatin and capecitabine) 13. Known conditions that would interfere with treatment with any of the substances used in this study 14. Participation in another clinical study within the past 30 days 15. Concurrent malignancies or invasive cancers diagnosed within the past 5 years, except for: adequately treated basal cell cancer of the skin or in situ cancer of the cervix 16. Legal incapacity or limited legal capacity
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to determine the response rates of matuzumab in combination with ECX as background chemotherapy and of ECX alone in subjects with metastatic esophago-gastric cancer.;Secondary Objective: The secondary objectives of this study are to assess the following parameters: • Response duration • Median time to tumor progression • Median survival time • Safety and tolerability • Quality of life • Protein biomarkers In addition, the following parameters will be assessed for subjects receiving matuzumab • Determination of HAHA • Matuzumab peak and trough values ;Primary end point(s): The primary target variable is the tumor response rate based on response assessments made by the Independent Review Committee. Subjects in both groups will be evaluated for tumor response every 6 weeks during treatment (regardless of any treatment delays), and every 3 months after the end of all study treatment, until PD. Response will be classified according to the modified WHO criteria. | — |
Countries
Germany, Spain, United Kingdom
Outcome results
None listed