Clinical trial NCT00678535 (phase 3, status: completed)
Conditions: gastric cancer
ICD codes: C05.2, C10.0, C16.0, C16.4, C17.0, C17.1, C17.2
Drugs: cetuximab, capecitabine, cisplatin
SMILES: [H][C@]12SCC(COC(C)=O)=C(N1C(=O)[C@H]2NC(=O)C(=N/OC)\C1=CSC(N)=N1)C(O)=O, [H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1, [H][C@@]12N(C)C3=CC(OC)=C(C=C3[C@@]11CCN3CC=C[C@](CC)([C@@]13[H])[C@@]([H])(OC(C)=O)[C@]2(O)C(=O)OC)[C@]1(C[C@@]2([H])CN(CC(CC)=C2)CC2=C1NC1=CC=CC=C21)C(=O)OC
Eligibility criteria:

        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