This trial is active, not recruiting.

Condition leukemia
Treatment erlotinib
Phase phase 2
Target EGFR
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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
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.
erlotinib Erlotinib Hydrochloride
Starting dose: 150 mg by mouth once daily in a 28-day cycle.

Primary Outcomes

Overall Response Rate (ORR)
time frame: 28 days

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: 1. 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. 2. Age >/=18 years 3. ECOG Performance Status

Additional Information

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.
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by M.D. Anderson Cancer Center.