The purpose of this study is to determine how effective, and to what extent, Iressa is in
the treatment of acute myelogenous leukemia.
Patients will receive Iressa daily until either disease progression or intolerable toxicity
develops. On Day 1 of treatment, a physical exam and bloodwork will be performed. Once
weekly for the first 8 weeks, a physical exam and complete blood count with differential
will be performed.
For the first year, a physical exam, bloodwork will be performed monthly. Bone marrow
biopsies will be performed after the first month of therapy and then every 3 months for the
first year. After the first year a physical exam, bloodwork will be performed every 3 months
and bone marrow biopsies every 6 months.
- Patients must have pathologically documented acute myelogenous leukemia and either
not be a candidate for myelosuppressive chemotherapy due to age or comorbid disease;
or have relapsed acute myelogenous leukemia or be refractory to standard therapy and
not likely to require cytoreductive therapy within 30 days.
- ECOG performance status 0, 1 or 2
- Age > 18 years
- Adequate kidney and hepatic function
- Greater than 4 weeks from any chemotherapy, radiotherapy, immunotherapy, or systemic
steroid therapy with the exception of hydroxyurea.
- Greater than 2 months following bone marrow or peripheral blood stem cell
transplantation or donor lymphocyte infusion.
- Uncontrolled active infection
- Urgent need for cytoreductive chemotherapy, surgery, or radiotherapy
- Current chemotherapy or chemotherapy within the last 4 weeks.
- Pregnancy or nursing mothers
- Infection with HIV