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 < 2 (See Appendix E)
• Adequate bone marrow function (WBC>3,000/µL, ANC>1,500/µL, and platelets>100,000/µL, Hb>8g/dl)
• Adequate kidney function (creatinine<1.5 mg/dL)
• Adequate liver function [bilirubin< 2.0 mg/dL, transaminases levels<3 times the Upper Normal Value (5 times for patients with liver metastasis)]
• Prothrombin time not less than 50% of Lower Normal Value
• No prior chemotherapy
• No prior radiation therapy
• Patients must not have psychological, familial, sociological or geographical conditions which do not permit medical follow-up and compliance with this study.
• Women of childbearing potential must have a negative serum HCG pregnancy test on admission. Men and women of reproductive potential must have agreed to use an effective method of contraception while on treatment and for 6 months after study treatment.

Exclusion Criteria:

• Past or concurrent history of neoplasm other than gastric adenocarcinoma within the last five years, except for curatively treated non-melanoma skin cancer or in situ carcinoma of the cervix uteri.
• Central nervous system (CNS) metastases.
• Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to study treatment start
• Gastric outlet obstruction, intestinal obstruction and obvious peritoneal seeding.
• Evidence of serious gastrointestinal bleeding.
• The patient has bony lesions as the sole evaluable disease.
• Pregnant or lactating women, women of childbearing potential not employing adequate contraception.
• Patients with sensory neuropathy (grade> 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.