Docetaxel and Epirubicin in Advanced Gastric Cancer

Inclusion Criteria:

• Male and female outpatients ≥ 18 years,
• ECOG performance status below 1, with histologically confirmed as gastric adenocarcinoma with inoperable and/or metastatic disease.
• Patients must have at least one target lesion with a minimum lesion size as per the RECIST criteria (at least 1 unidimensional measurable lesion ≥ 20 mm in diameter by conventional CT or MRI scan, or ≥ 10 mm in diameter by spiral CT scan).
• Creatinine clearance ≥ 60ml/min (estimated creatinine clearance must be calculated at baseline for all patients.)
• Adequate major organ function : - Hematopoietic function: WBC>4,000/mm3 or ANC> 2,000/mm3, Platelet count ≥ 100,000/mm3,- Hepatic function: Bilirubin 1 x UNL (Upper normal limit), AST/ALT levels <2.5X UNL, alkaline phosphatase < 5 x UNL (except in case of bone metastasis without any liver disease) - Renal function: Creatinine <1 x UNL or creatinine clearance ≥ 60ml/min.

Exclusion Criteria:

• Patients must not have previously received systemic treatment (cytotoxic chemotherapy or active/passive immunotherapy) for advanced or metastatic disease.
• Adjuvant or neo-adjuvant treatment for non-metastatic (M0) disease is allowed if completed at least 6 months prior to initiation of study treatment.
• The following laboratory values: - neutrophils ≤1.5 X 109 /L, platelet count<100 X 109 /L- serum bilirubin ≥ 1.5 X upper normal limit-ALAT, ASAT > 2.5 X upper normal limit or > 5 X upper normal limit in the case of liver metastases- Alkaline phosphatase > 2.5 X upper normal limit or 5 X upper normal limit in the case of liver metastases or > 10 X upper normal limit in the case of bone disease.
• Prior therapy with Taxotere or Epirubicin is excluded.