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 - MATRIX E.G.
- Conditions
- Metastatic Esophago-gastric adenocarcinomaMedDRA version: 9.1Level: LLTClassification code 10001150Term: Adenocarcinoma gastric
- Registration Number
- EUCTR2005-000146-36-DE
- Lead Sponsor
- Merck KGaA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 70
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 < 1.5 x upper limit of normal (ULN)
•Alanine aminotransferase (ALT)/aspartate aminotransferase (AST) < 2.5 x ULN (for subjects with liver metastases ALT/AST < 5 x ULN)
•Neutrophils > 1500 mm3
•Platelets > 100 000/µl
•Hemoglobin > 10g/dl
•Serum creatinine < 1.5 x ULN or glomerular filtration rate (GFR) of =? 60 ml/minute. The GFR is to be based upon the Cockroft-Gault formula for creatinine clearance:
GFR (ml/min) = c x (140 – age [years]) x weight (kg)
72 x serum creatinine (mg/100 ml)
where c = 0.85 for female subjects and c = 1.00 for male subjects
11.If of childbearing potential, willingness to use effective contraceptive method for the study duration and 2 months post-dosing. [Females of childbearing potential are defined as any females who have experienced menarche and have not undergone successful surgical sterilization (hysterectomy or bilateral oophorectomy), or are not post menopausal (defined as age-related amenorrhea for =12 consecutive months)]
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method