A Phase I/II Study of Vorinostat (Zolinza®) in Combination With Capecitabine (X) and Cisplatin (P) for 1st Line Treatment of Metastatic or Recurrent Gastric Cancer
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
