Study of XELOX With Cetuximab in Advanced Gastric Cancer

Inclusion Criteria

• Having given signed written informed consent
• Patients must have histologically or cytologically documented stomach adenocarcinoma including adenocarcinoma of the esophagogastric junction.
• Patients must have unresectable metastatic disease or recurrent disease after curative surgical resection with uni-dimensionally measurable disease according to RECIST (at least longest diameter 1 cm on computed tomography scan, or at least 2 cm on chest x-ray or physical examination
• Age 18 to 70 years old
• Estimated life expectancy of more than 3 months
• ECOG performance status 3, 000/µL, ANC>1,500/µL, and platelets>100,000/µL, Hb>8g/dl)
• Adequate kidney function (creatinine 1 according to NCI CTCAE v. 3.0).
• Hypersensitivity to any of the study drugs or ingredients.
• Other serious illness or medical conditions that would not allow study participation in the best interest of the patient as decided by the investigator.
• Unstable cardiac disease despite treatment, myocardial infarction within 6 months prior to study entry.
• History of significant neurologic or psychiatric disorders including dementia or seizures.
• Active uncontrolled infection.
• Pre-existing clinically significant diarrhea.
• Unstable diabetes mellitus.
• Severe hypercalcemia of > 12 mg/dL and uncontrolled with bisphosphonates.
• Active disseminated intravascular coagulation.
• Concurrent treatment with corticosteroids (or equivalent) except as use for the prophylactic medication regimen, treatment of acute hypersensitivity reactions or nausea, or unless chronic treatment (initiated > 6 months prior to study entry) at low dose (<20 mg methyl prednisolone or equivalent).
• Concomitant or administration of any other experimental drug under investigation within 4 weeks before the study.
• Concomitant or previous hormonal therapy, or immunotherapy.