Trial of Panitumumab Cisplatin, Fluourouracil and Docetaxel in Locally Advanced or Metastatic Gastric Cancer

Inclusion Criteria:

• Histologically proven inoperable locally advanced or metastatic adenocarcinoma of the stomach (including adenocarcinoma of the gastrooesophageal junction)
• Patient's age between 20 and 70 years old
• Measurable disease defined by RECIST criteria
• Patients with non-measurable disease could be enrolled in the phase I part of the study
• ECOG performance status ≤ 1
• Hgb ≥ 8g/dL, WBC ≥ 3 x 109/L , neutrophils count ≥ 1.5 x 109/L , platelets ≥100 x 109/L, Creatinine clearance ≥50 mL/min, Total bilirubin ≤ 1.5 X UNL, AST, ALT and ALP ≤ 2.5 x UNL
• No prior chemotherapy or more than 6 months from adjuvant chemotherapy or chemo-radiation
• Estimated life expectancy more than 3 months
• Written informed consent

Exclusion Criteria:

• Gastrointestinal bleeding
• Clinically relevant, symptomatic excessive amounts of ascites resulting in patient's discomfort
• CNS metastases
• History of hypersensitivity to fluoropyrimidines, docetaxel or platinum compounds
• Any previous chemotherapy or radiotherapy for advanced disease
• Patient pregnant or breast feeding, or planning to become pregnant within 6 months after the end of treatment
• Patient (male or female) is not willing to use highly effective methods of contraception (per institutional standard) during treatment and for 6 months (male or female) after the end of treatment
• Known hypersensitivity reaction to the component of the treatment
• Active infection or malnutrition or bowel obstruction
• Legal incapacity or limited legal capacity
• Definite contraindications for the use of corticosteroids
• History of interstitial lung disease e.g. pneumonitis or pulmonary fibrosis or evidence of interstitial lung disease on baseline chest CT scan
• Chronic inflammation of the bowel
• Clinically significant cardiovascular disease (including myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) ≤ 1 year before enrollment
• Medical or psychological condition which in the opinion of the investigator would not permit the subject to complete the study or sign meaningful informed consent
• A second primary tumor other than non-melanoma skin cancer or in situ cervical cancer