Amrubicin + Cyclophosphamide in Advanced Solid Organ Malignancies

OUTLINE: This is a multi-center study. This study will follow the 3+3 design with the following dose levels: * Dose Level -1: Amrubicin 20mg/m2, Cyclophosphamide 500mg/m2 * Dose Level 1: Amrubicin 25mg/m2, Cyclophosphamide 500mg/m2 * Dose Level 2: Amrubicin 30mg/m2, Cyclophosphamide 500mg/m2 * Dose Level 3: Amrubicin 35mg/m2, Cyclophosphamide 500mg/m2 * Dose Level 4: Amrubicin 40mg/m2, Cyclophosphamide 500mg/m2 Dose escalation starts from dose level 1. Amrubicin will be given as a slow IV push or infusion over approximately 5 minutes once daily for 3 consecutive days starting on day 1 of each 21 day cycle. Cyclophosphamide will be given at a fixed dose as an IV infusion over 30-60 minutes on day 1 of each 21 day cycle (following amrubicin). ECOG Performance Status: 0-1 Life expectancy: not specified Hematopoietic: * Hemoglobin (Hgb) \> 9 g/dL. * Platelets \> 100 K/mm3 * Absolute Neutrophil Count (ANC) \> 1.5 K/mm3 Hepatic: * Aspartate transaminase (AST) ≤ 2.5 x ULN * Alanine transaminase (ALT) ≤ 2.5 x ULN * Total bilirubin \< 1.5 x ULN Renal: * Calculated creatinine clearance ≥ 60cc/min Cardiovascular: * Left Ventricular Ejection Fraction (LVEF) ≥ LLN for institution within 60 days prior to registration for protocol therapy. * No history of cardiomyopathy or uncontrolled heart arrhythmia. Pulmonary: * No suspected, diffuse idiopathic interstitial lung disease or history of pulmonary fibrosis.