Pilot Phase II - Erlotinib for Acute Myeloid Leukemia (AML)
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Pilot Phase II Study of Erlotinib for the Treatment of Patients With Refractory/Relapsed Acute Myeloid Leukemia (AML)|
- Overall Response Rate (ORR) [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]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).
|Study Start Date:||May 2013|
|Estimated Primary Completion Date:||May 2017 (Final data collection date for primary outcome measure)|
Patients receive therapy with erlotinib administered orally as a continuous daily dose in 28-day cycles. Patients will continue therapy until clinically significant progression of the disease or unacceptable toxicity.
Erlotinib starting dose 150 mg by mouth, once daily in 28-day cycles.
Starting dose: 150 mg by mouth once daily in a 28-day cycle.
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 are taking.
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 erlotinib.
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 minutes.
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 purposes only.
Up to 29 patients will take part in this study. All will be enrolled at MD Anderson.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01664897
|United States, Texas|
|University of Texas MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Jorge Cortes, MD||M.D. Anderson Cancer Center|