Inadequate organ function, evidenced by the following laboratory results: a. Absolute neutrophil count < 1000 cells/mm3. b. Platelet count < 75,000 cells/mm3. c. Uncorrectable grade 3 anemia (hemoglobin < 8 g/dL). d. Total bilirubin greater than the upper limit of normal (ULN; unless the subject has documented Gilbert’s syndrome). e. Aspartate aminotransferase (AST [SGOT]) or alanine aminotransferase (ALT [SGPT]) > 2.5 × ULN (> 5 × ULN in subjects w ith liver metastases). f. Alkaline phosphatase levels > 2.5 × ULN (> 5 × ULN in subjects with liver metastases, or >10 × ULN in subjects with bone metastases). g. Serum creatinine > 2.0 mg/dL or 177 μmol/L. h. Serum anion gap > 16 mEq/L or arterial blood with pH < 7.3. 6. Uncontrolled hypertension (systolic > 160 mm Hg and/or diastolic > 110 mm Hg) or clinically significant (ie, active) cardiovascular disease, cerebrovascular accident/stroke, or myocardial infarction within 6 months prior to first study medication; unstable angina; congestive heart failure of New York Heart Association grade 2 or higher; or serious cardiac arrhythmia requiring medication. Subjects with uncontrolled hypertension should be medically managed on a stable regimen to control hypertension p rior to study entry. 7. Serious myocardial dysfunction defined by ECHO as absolute left ventricular ejection fraction (LVEF) 10% below the institution’s lower limit of predicted normal. 8.