 - Patient has any of the following laboratory results within 30 days prior to the first dose of study medication: Hemoglobin concentration 8.0 gdL; Absolute neutrophil count 750 cellsmm3; Platelet count 50,000 cells mm3; Aminotransferase AST, ALT 3 times ULN; Serum creatinine 1.5 times the Upper Limits of Normal ULN 