Cetuximab in Combination With S-1 and Cisplatin in Gastric Cancer
Condition: Gastric Cancer
MeSH terms: Stomach Neoplasms
Intervention: Cetuximab; Cisplatin; S-1
Intervention description: Single first dose of cetuximab 400 milligram per square meter (mg/m^2) will be administered intravenously followed by once weekly subsequent intravenous infusion of cetuximab 250 mg/m^2 in each 5-week treatment cycle until disease progression, unacceptable toxicity, or withdrawal of consent.; Cisplatin 60 mg/m^2 will administered as intravenous infusion on Day 8 of each 5-week cycle maximum up to 8 cycles until disease progression, unacceptable toxicity, or withdrawal of consent; S-1, a combination of tegafur, gimeracil, and oteracil will be administered intravenously at a dose of 40 to 60 mg/m^2 orally twice daily for first three consecutive weeks of 5-week cycle until disease progression, unacceptable toxicity, or withdrawal of consent.
Intervention MeSH terms: Cetuximab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 40.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No
Keywords: Gastric Cancer; Cetuximab; EMD271786; TS-1; Cisplatin

Summary:

      This open-label, single-arm, multicenter, Phase 2 trial will treat at least 40 participants
      with advanced gastric adenocarcinoma including adenocarcinoma of the gastroesophageal
      junction (GEJ) who have not previously received systemic chemotherapy for this setting.

      All eligible participants will receive the combination of cetuximab plus S-1 (a combination
      of tegafur, gimeracil, and oteracil) and cisplatin.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Written informed consent and agreement with medically accepted contraception (in
             participants with conception potential) are obtained

          -  Japanese participants aged greater than or equal to 20 years

          -  Histologically confirmed adenocarcinoma of the stomach or GEJ (adenocarcinomas of the
             esophagogastric junction types I to III according to Siewert's classification) in
             Stage M0 (unresectable advanced) or Stage M1 (unresectable metastatic) of the disease

          -  Archived tumor material sample for at least subsequent standardized epidermal growth
             factor receptor (EGFR) expression and Kirsten-rat sarcoma (KRAS) mutation assessments

          -  At least one radiographically documented measurable lesion in a previously
             non-irradiated area according to the RECIST v 1.0

          -  Eastern Cooperative Oncology Group - performance status (ECOG-PS) 0 to 1

          -  Estimated life expectancy greater than 12 weeks

          -  Renal, liver and hematopoietic function as defined in the protocol.

          -  Sodium and potassium within normal limits or as defined in the protocol

          -  Other protocol defined inclusion criteria could apply

        Exclusion Criteria:

          -  Prior therapies: prior treatment with an antibody or molecule targeting EGFR- and/or
             vascular endothelial growth factor (VEGF) receptor-related signaling pathways;
             chemotherapies; or radiotherapies, major surgeries, and any investigational drugs in
             the 30 days before the start of trial treatment

          -  Concurrent chronic systemic immune or hormone therapy not indicated in this trial
             protocol any contraindication to treatment with cetuximab and cisplatin, or any
             treatments with prohibited concomitant drugs

          -  Brain metastasis and/or leptomeningeal disease

          -  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 last 12
             months, or high risk of uncontrolled arrhythmia

          -  Chronic diarrhea or short bowel syndrome

          -  Known Human Immunodeficiency Virus (HIV) infection, active or chronic carrier of
             hepatitis B virus (HBV) (HBV antigen positive or HBV deoxyribonucleic acid (DNA)
             positive) or hepatitis C virus (HCV) (HCV antibody positive)

          -  Pregnancy or lactation period

          -  Concurrent treatment with a non-permitted drug (any other chemotherapy, systemic
             anticancer therapy or immunotherapy)

          -  Previous malignancy other than gastric cancer in the last 5 years Medical or
             psychological conditions that would not permit the participant to complete the trial
             or sign the Informed Consent Form (ICF)

          -  Legal incapacity or limited legal capacity

          -  Other protocol defined exclusion criteria could apply