Study of Docetaxel, Capecitabine and Oxaliplatin in Advanced Stomach Cancer

Inclusion Criteria:

• Histologically confirmed unresectable or metastatic advanced gastric adenocarcinoma
• Completion of adjuvant chemotherapy 6 months before the study, or no previous chemotherapy (But, patients who received docetaxel, capecitabine, or oxaliplatin as adjuvant chemotherapy should be excluded.)
• Age 18 to 70 years old
• Eastern Cooperative Oncology Group performance status 0~2
• Adequate bone marrow function: white blood cell counts >4,000/µL, absolute neutrophil count >2,000/µL, and platelets>100,000/µL
• Adequate renal function: creatinine < 1 x upper normal limit (UNL) or creatinine clearance 60ml/min
• Adequate hepatic function: bilirubin < 1.5 x UNL, aspartate aminotransferase (AST)/alanine aminotransferase (ALT) levels < 2.5 x UNL, and alkaline phosphatase < 5 x UNL (except in case of bone metastasis without any liver disease)
• Given written informed consent prior to study-specific screening procedures, with the understanding that the patient has the right to withdraw from the study at any time, without prejudice

Exclusion Criteria:

• Contraindication to any drug contained in the chemotherapy regimen
• Other tumor type than adenocarcinoma
• Presence or history of central nervous system (CNS) metastasis
• Gastric outlet or bowel obstruction
• Evidence of serious gastrointestinal bleeding
• Peripheral neuropathy > grade 1
• History of significant neurologic or psychiatric disorders
• History of another malignancy within the last five years except cured basal cell carcinoma of skin and cured carcinoma in-situ of uterine cervix
• Pregnant or lactating women, women of childbearing potential not employing adequate contraception. Postmenopausal women must have been amenorrheic for at least 12 months to be considered of non-childbearing potential
• Sexually active males and females (of childbearing potential) unwilling to practice conception during the study
• Clinically significant cardiac disease (e.g. severe non-compensated hypertension, non-compensated heart failure, dilated cardiomyopathy, and coronary heart disease with ST segment depression in electrocardiogram) or myocardial infarction within the last 6 months
• Serious pulmonary conditions/illness (e.g. chronic lung disease with hypoxemia)
• Serious metabolic disease such as severe non-compensated diabetes mellitus
• Serious uncontrolled intercurrent infections, or other serious uncontrolled concomitant disease
• Positive serology for the human immunodeficiency virus (HIV)