Pilot Study of Erlotinib for the Treatment of Patients With de Novo Acute Myeloid Leukemia
Condition: Leukemia, Myelomonocytic, Acute
MeSH terms: Leukemia; Leukemia, Myeloid, Acute; Leukemia, Myelomonocytic, Acute
Intervention: Erlotinib
Intervention description: Erlotinib will be administered orally at 150 mg once a day, continuously. Each cycle will be 28 days and there will be no break between the cycles.
Intervention MeSH terms: Erlotinib Hydrochloride
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 11.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Leukemia, Myelomonocytic, Acute; Erlotinib

Summary:

      This research study is looking for patients with newly diagnosed acute myeloid leukemia
      (AML), AML that has returned (relapsed), or it has not responded adequately to previous
      treatments. Treating certain patients with chemotherapy may not be to their benefit or may
      cause more harm than benefit. The purpose of this study is to find out what effects (good and
      bad) erlotinib has on patients and their AML.
    

Eligibility criteria:

        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.