Pilot Study of Erlotinib for the Treatment of Patients With de Novo Acute Myeloid Leukemia

Inclusion Criteria:

- Diagnosis of AML with no history of previous clonal/malignant hematologic disorders
such as myelodysplastic syndromes or myeloproliferative disorders.

- Newly diagnosed patients will be age 70 or older

- Relapses patients will be age 60 or older any time following first relapse, if
patient is not considered candidate/not interested in salvage chemotherapy.

- Refractory disease patients will be age 18-59 who have failed at least 2 lines of
conventional chemotherapy (1 induction and 1 salvage)

- Patient must have discontinued all previous therapies for AML at least 14 days and
recovered from the non-hematologic side effects of the therapy.

- Laboratory tests must be within protocol-specified ranges

- Patient must be able to swallow and tolerate oral medication.

Exclusion Criteria:

- Patients with known central nervous system (CNS) leukemia by spinal fluid cytology,
flow cytometry or imaging.

- History of antecedent pre-leukemic hematologic disorders such as myelodysplastic
syndromes or myeloproliferative disorders.

- Diagnosis of acute promyelocytic leukemia (APL)

- Patients who require chronic anticoagulation, are current smokers or who are taking
rifabutin, rifapentine, phenytoin, carbamazepine, phenobarbital and St. John's Wort
are not eligible.

- Patients with active corneal erosions or history of abnormal corneal sensitivity
test.

- Patients with serious illness such as: significant ongoing or active infection, New
York Heart Association (NYHA) Grade II or greater congestive heart failure, unstable
angina (anginal symptoms at rest), new onset angina (began within the last 3 months),
myocardial infarction within the past 6 months, cardiac ventricular arrhythmias
requiring anti-arrhythmic therapy, cerebrovascular accident within past 3 months, or
psychiatric illness that would limit compliance with the study requirements.