Open-label, Randomized, Controlled, Multicenter Phase III Study Investigating Cetuximab in Combination With Capecitabine (Xeloda, X) and Cisplatin (P) Versus XP Alone as First-line Treatment for Subjects With Advanced Gastric Adenocarcinoma Including Adenocarcinoma of the Gastroesophageal Junction
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