Study of Vorinostat Plus Capecitabine (X) and Cisplatin (P) for 1st Line Treatment of Metastatic or Recurrent Gastric Cancer: Zolinza+XP

Inclusion Criteria:

• Histologically confirmed unresectable or metastatic advanced gastric adenocarcinoma
• Completion of adjuvant chemotherapy 6 months before the study, or no previous chemotherapy
• Age 18 to 70 years old
• Eastern Cooperative Oncology Group (ECOG) performance status 2 or less
• Estimated life expectancy of more than 3 months
• Presence of measurable or evaluable disease
• Adequate bone marrow function (ANC >1,500/µL and platelets>100,000/µL),
• Adequate renal function: creatinine < 1 x upper normal limit (UNL) or creatinine clearance 60ml/min or less
• Adequate hepatic function: bilirubin < 1.5 x UNL, aspartate aminotransferase (AST)/alanine aminotransferase (ALT) levels < 2.5 x UNL (< 5 x upper limit of normal for patients with liver involvement of their cancer), alkaline phosphatase < 5 x UNL (except in case of bone metastasis without any liver disease)
• Written informed consent

Exclusion Criteria:

• Prior exposure to any histone deacetylase (HDAC) inhibitor (however, valproic acid would be allowed if a 30-day wash-off period is provided.)
• Previous adjuvant treatment with capecitabine or platinums
• 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 2
• 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
• Active human immunodeficiency virus (HIV) infection
• Viral hepatitis infections
• Other serious illness or medical conditions