 - Alkaline phosphatase ALP, aspartate aminotransferase AST, alanine aminotransferase ALT, or total bilirubin greater or equal to 2X the upper limit of normal; hemoglobin Hb 8.0 gmdL; platelet count greater than or equal to 800,000mL; ANC less than or equal to 1,000μL or 20,000μL the exclusion of subjects with ANC 20,000μL applies only to entry into the first treatment cycle 