
    slow accrual-2 patients were registered phase i and none in phase ii
  
['leukemia']
['omacetaxine', 'decitabine']

        Inclusion Criteria:

          1. Previously untreated AML (>/= 20% blasts) or AML M6. Patients with high-risk
             (intermediate-2 or high by IPSS or >/= 10% blasts) MDS will also be eligible. Prior
             therapy with hydroxyurea, biological or targeted therapy (e.g. flt3 inhibitors, other
             kinase inhibitors, azacitidine), or hematopoietic growth factors is allowed. No prior
             chemotherapy is allowed except for a single or a two day dose of cytarabine (up to 3
             g/m2) for emergency use is also allowed as prior therapy.

          2. Age >/= 70 years.

          3. Eastern Cooperative Oncology Group (ECOG) performance status </= 2.

          4. Adequate hepatic (serum total bilirubin </= 1.5 x ULN, serum glutamate pyruvate
             transaminase (SGPT) and/or SGOT </= 2.5 x ULN) and renal function (creatinine </= 2.0
             mg/dL).

          5. Patients must be willing and able to review, understand, and provide written consent
             before starting therapy.

          6. Men of childbearing potential who agree to use contraception prior to study entry and
             for the duration of participation.

        Exclusion Criteria:

          1. New York Heart Association (NYHA) class III or IV heart disease, active ischemia or
             any other uncontrolled cardiac condition such as angina pectoris, clinically
             significant cardiac arrhythmia and requiring therapy, uncontrolled hypertension (blood
             pressure >/= 160 systolic and >/= 110 diastolic not responsive to antihypertensive
             medication), uncontrolled diabetes mellitus, or congestive heart failure.

          2. Myocardial infarction in the previous 12 weeks (from the start of treatment).

          3. Active and uncontrolled disease/infection as judged by the treating physician.

          4. Acute promyelocytic leukemia (APL).
      