Eligibility Criteria

Pts with a cytologically or histologically confirmed advanced or recurrent gastric cancer refractory to conventional therapy were candidates for this study. Pts with a serious infection including HBsAg, HCVab, syphilis, HIV positive, uncontrollable hypertension, brain metastasis showing symptoms, allergy against anthracycline-type drugs, cardiofunction disorders (e.g., pt with suspected congestive heart failure, pt with a treatment history of congestive heart failure, pt with a history of myocardial infarction, and pt with an electrocardiographic abnormality who requires pharmacotherapy.), vascular disorder including a history of pulmonary embolism, deep venous thrombosis, and peripheral artery occlusive disease were excluded. Pts were also excluded if they were pregnant or lactating, or showing gastrointestinal bleeding. Also, pts for whose principal investigator or investigators considered ineligible were excluded. Eligibility criteria also included the following: (1) World Health Organization performance status of = 2; (2) age = 20 years, < 75 years; (3) normal hematologic (WBC count = 4,000/jiL; platelet count = 100,000/^iL), hepatic (Total bilirubin level = 1.5mg/dL; AST and ALT = 2.5 times the upper limit of normal, unless the elevation was a result of hepatic metastasis, in which case elevations 3

a humanized monoclonal Ah against ยก1 cell surface moleculc of gastric cancer

Figure I. Structure of MCC-465

times the upper normal limits were permitted), renal (serum creatinine = the upper limit of normal), cardiac (NYHA = 1), pulmonary function (Pa02 = (4) no anticancer therapy in the previous 4 weeks for radiotherapy and chemotherapy (6 weeks for nitrosoureas and mitomycin) before administration of MCC-465, confirmation of history of anthracyclin treatment and doxorubicin dose = 100mg/m2 or epi- or pira-rubicin dose = (5) life expectancy of 3 months: (6) no coexisting medical problems of sufficient severity; (7) full recovery from toxicity caused by other test drug previously administrated. The institutional review boards for each hospital approved the protocol and informed-consent brochures. All pts gave written informed consent at study entry.

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