 11. Adequate organ function as defined: serum aspartate transaminase AST and serum alanine transaminase ALT 3 x upper limit of normal ULN if no metastatic liver involvement, or 5 if liver involvement; total serum bilirubin 1.5 x ULN; absolute neutrophil count ANC 1500uL; platelets 100,000uL; hemoglobin 9.0 gdL; serum albumin 3.0 gdL; serum creatinine 2.0 mgdL or calculated creatinine clearance 60 mlmin; PT or INR or PTT 1.5 x ULN. Subject may not have received any growth factors or blood transfusions within 7 days of the hematologic laboratory values obtained at the Screening visit. 