A Pilot Phase II Study of Erlotinib for the Treatment of Patients With Refractory/Relapsed Acute Myeloid Leukemia (AML)
Study Drug Administration:
Each cycle is 28 days.
You will take erlotinib by mouth 1 time each day.
If you have severe side effects from the study drug, the study doctor may decide to stop
your drug dosing until the side effects get better.
Every week for the first 3 months and then every 2-4 weeks after that, blood (about 1
tablespoon) will be drawn for routine tests and to test your liver and kidney function.
After 6 months, blood will be drawn every 6-8 weeks.
At the end of Cycle 1 and then every 2-3 months after that, you will have a complete
physical exam, and you will be asked about any side effects you may have or any drugs you
At the end of Cycle 1 and then every 2-3 months after that for 1 year, you will have a bone
marrow aspirate. After 1 year, you will only have additional bone marrow aspirates
performed if the study doctor thinks it is necessary.
If you have no significant side effects during the first 12 months, the number of blood
draws and bone marrow collections may be lowered to 1 every 1-3 cycles.
You may continue taking the study drug for as long as the study doctor thinks it is in your
best interest. You will no longer be able to take the study drug if the disease gets worse,
if intolerable side effects occur, or if you are unable to follow study directions.
You will have an end-of-treatment visit 30 days (+/- 7 days) after your last dose of
At this visit, you will be asked about any symptoms and/or side effects you may have. The
end-of-treatment visit can be done by phone or during one of your standard of care clinic
visits at MD Anderson. If this visit is done by phone, the call should last about 15
This is an investigational study. Erlotinib is not FDA approved and commercially available
for the treatment of AML. In this disease type, it is currently being used for research
Up to 29 patients will take part in this study. All will be enrolled at MD Anderson.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Overall Response Rate (ORR)
Primary efficacy endpoint is overall response (ORR) as assessed by investigators. An adequate response, included in ORR for this trial will include all of the following obtained within the first 3 months of therapy: complete remission (CR), complete remission with incomplete blood count recovery (CRi), partial remission (PR), and morphologic leukemia-free state (MLF).
Jorge Cortes, MD
UT MD Anderson Cancer Center
United States: Food and Drug Administration
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