Pilot Phase II - Erlotinib for Acute Myeloid Leukemia (AML)
This trial is active, not recruiting.
|Sponsor||M.D. Anderson Cancer Center|
|Collaborator||Astellas Pharma Inc|
|Start date||May 2013|
|End date||May 2018|
|Trial size||29 participants|
|Trial identifier||NCT01664897, 2012-0060, NCI-2012-02073|
The goal of this clinical research study is to learn if erlotinib can help to control AML. The safety of this drug will also be studied.
|Endpoint classification||safety/efficacy study|
|Intervention model||single group assignment|
Overall Response Rate (ORR)
time frame: 28 days
Male or female participants at least 18 years old.
- Patients with AML who have either been refractory to prior therapy or have relapsed after prior therapy. Patients with MDS or CMML who received therapy with a hypomethylating agent and progress to AML are eligible if they have received any therapy for MDS and failed (i.e., lack or loss of response) regardless of whether they have received therapy for AML or not. The WHO classification will be used for AML.
- Age >/=18 years
- ECOG Performance Status </=2
- Adequate liver (total bilirubin </=2x ULN, ALT </=2.5x ULN) and renal (creatinine </=2x ULN) function.
- Patients must provide written informed consent.
- Patients must have been off chemotherapy for 2 weeks prior to entering this study, unless there is evidence of rapidly progressive disease, and must have recovered from the clinically significant toxic effects of that therapy to at least grade 1. Use of hydroxyurea for patients with rapidly proliferative disease is allowed before the start of study therapy and for the first four weeks on therapy.
- Patients - both males and females - with reproductive potential (ie, menopausal for less than 1 year and not surgically sterilized) must practice effective contraceptive measures throughout the study. Women of childbearing potential must provide a negative pregnancy test (serum or urine) within 14 days prior to initiation of study.
- Patients with known allergy or hypersensitivity to erlotinib.
- Patients with any other known disease (except carcinoma in-situ) concurrent severe and/or uncontrolled medical condition (e.g. uncontrolled diabetes; cardiovascular disease including congestive heart failure NYHA Class III or IV, myocardial infarction within 6 months, and poorly controlled hypertension; chronic renal failure; or active uncontrolled infection) which, in the opinion of the investigator could compromise participation in the study.
- Patients unwilling or unable to comply with the protocol.
- Significant gastrointestinal disorders that may interfere with absorption of erlotinib.
- Patients who can receive a stem cell transplant within 4 weeks.
|Official title||A Pilot Phase II Study of Erlotinib for the Treatment of Patients With Refractory/Relapsed Acute Myeloid Leukemia (AML)|
|Principal investigator||Jorge Cortes, MD|
|Description||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. Study Visits: 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. Length-of-Study: 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. End-of-Treatment Visit: 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.|
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