Erbitux in Combination With Xeloda and Cisplatin in Advanced Esophago-gastric Cancer (EXPAND)

This is an interventional treatment trial for Gastric Cancer focused on measuring 1st line treatment for Gastric Cancer, Cetuximab, Capecitabine, Xeloda, Cisplatin, Progression-free survival Read More

Inclusion Criteria:

• Written informed consent before any study-related activities are carried out
• Age greater than or equal to (>=) 18 years
• Histologically confirmed adenocarcinoma of the stomach or gastroesophageal junction (Adenocarcinoma of the gastroesophageal junction [AEG] Types I-III according to Siewert classification)
• Archived tumor material sample for at least subsequent standardized Epidermal Growth Factor Receptor (EGFR) expression assessment
• Unresectable advanced (M0) or unresectable metastatic (M1) disease
• At least one radiographically documented measurable lesion in a previously non-irradiated area according to response evaluation criteria in solid tumors (RECIST). The primary tumor site is to be considered as a non-measurable lesion only
• Eastern Cooperative Oncology Group (ECOG) performance status 0-1
• Estimated life expectancy greater than (>) 12 weeks
• Medically accepted contraception (if the risk of conception exists)
• Glomerular filtration rate (GFR) >= 60 milliliter per minute (mL/min) The GFR is based on the Cockcroft-Gault formula for creatinine clearance
• Aspartate-aminotransferase (ASAT) less than or equal to (=<) 2.5 * upper limit of normal (ULN) and alanine-aminotransferase (ALAT) =< 2.5 *ULN
• Bilirubin =< 3 * ULN
• Absolute neutrophil count (ANC) >= 1.5 * 10^9 per liter
• Platelets >= 100 * 10^9 per liter
• Hemoglobin >=10 gram per deciliter (g/dL) (without transfusions)
• Sodium and potassium within normal limits or =< 10 percent above or below (supplementation permitted)

Exclusion Criteria:

• Prior chemotherapy, however, previous (neo-)adjuvant (radio-) chemotherapy allowed if finished > 1 year prior to start of study treatment and no more than 300 mg/m^2 cisplatin has been administered
• Prior treatment with an antibody or molecule targeting EGFR and/or Vascular Endothelial Growth Factor Receptor (VEGFR) related signaling pathways
• Brain metastasis and/or leptomeningeal disease (known or suspected)
• Radiotherapy (except localized radiotherapy for pain relief), major surgery or any investigational drug within 30 days before the start of study treatment
• Concurrent chronic systemic immune or hormone therapy not indicated in this study protocol (except for physiologic replacement)
• Clinically relevant coronary artery disease (New York Heart Association [NYHA] functional angina classification III/IV), congestive heart failure (NYHA III/IV), clinically relevant cardiomyopathy, history of myocardial infarction in the 12 months before study Screening, or high risk of uncontrolled arrhythmia
• Active Hepatitis B or C
• Chronic diarrhea or short bowel syndrome

• Presence of any contra-indication to treatment with cetuximab, capecitabine and cisplatin including:

  • Known hypersensitivity to capecitabine, fluorouracil, cisplatin, cetuximab or to any of the excipients of these drugs
  • Known dihydropyrimidine dehydrogenase (DPD) deficiency
  • Hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
  • Current treatment with sorivudine or chemically related analogues, such as brivudine
  • Symptomatic peripheral neuropathy National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE) Grade >= 2 and/or ototoxicity NCI CTCAE Grade >= 2, except if due to trauma or mechanical impairment due to tumor mass
• Pregnancy or lactation period
• Concurrent treatment with a non-permitted drug
• Treatment in another clinical study within 30 days prior to study screening
• Previous malignancy other than gastric cancer within 5 years prior to study screening, except for basal cell cancer of the skin or pre-invasive cancer of the cervix
• Medical or psychological conditions that would not permit the subject to complete the study or sign informed consent
• Legal incapacity or limited legal capacity
• Significant disease which, in the Investigator's opinion, would exclude the subject from the study