10. Adequate organ function, defined by the following laboratory results obtained within 14 days prior to the first study treatment (Cycle 1, Day 1):f. Total bilirubin </= 1.5 x upper limit of normal (ULN) with the following the exception that patients with known Gilbert disease who have serum bilirubin level </=3 x ULN may be enrolled. g. AST and ALT </= 2.5 x ULN with the exception that patients with liver involvement: AST and/or ALT </= 5 x ULN h. Alkaline phosphatase </= 2.5 x ULN with the exception that patients with documented liver involvement or bone metastases: alkaline phosphatase </= 5 x ULN i. Serum creatinine </= 1.5 x ULN or creatinine clearance >/= 50 mL/min on the basis of the Cockcroft-Gault glomerular filtration rate estimation: (140 - age) x (weight in kg) x (0.85 if female)/72 x (serum creatinine in mg/dL)