A Phase II Study of Docetaxel and Epirubicin Combination in Patients With Advanced Gastric Cancer.
- 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.
- 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.