Pilot Study of Erlotinib for the Treatment of Patients With de Novo Acute Myeloid Leukemia
This research study is looking for patients with newly diagnosed acute myeloid leukemia (AML), AML that has returned (relapsed), or it has not responded adequately to previous treatments. Treating certain patients with chemotherapy may not be to their benefit or may cause more harm than benefit. The purpose of this study is to find out what effects (good and bad) erlotinib has on patients and their AML.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Pilot Study of Erlotinib for the Treatment of Patients With de Novo Acute Myeloid Leukemia|
- Overall Response Rate (Defined as Partial Remission or Better) to 3 Months of Treatment With Erlotinib [ Time Frame: 3 months of treatment with erlotinib ] [ Designated as safety issue: No ]The percent of patients were shown as having a partial remission or better based on definitions of response in AML. Partial remission includes a decrease of at least 50% in the percentage of blasts to 5% to 25% in the bone marrow aspirate. Complete remission includes presence of less than 5% blasts in an aspirate sample with marrow spicules and with a count of at least 200 nucleated cells. The percent and 95% exact confidence intervals will be calculated.
- Duration of Response (up to One Year Follow up) in Patients Who Achieve a Complete Remission [ Time Frame: 1 year after treatment discontinuation ] [ Designated as safety issue: No ]The duration of response is from the time of response until failure or until the end of follow-up for the patients who received complete remission. Complete remission includes presence of less than 5% blasts in an aspirate sample with marrow spicules and with a count of at least 200 nucleated cells.
- Treatment Related Adverse Events Grade 3 or Higher [ Time Frame: up to 15 months ] [ Designated as safety issue: Yes ]Adverse events will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. Grading scale will be from 1 (mild) to 5 (causing death). This will determine the number of unique patients who had a treatment related (possible, probable or definite) adverse event that was graded 3 or greater.
- Mechanistic Attributes of Erlotinib Hydrochloride in AML, Including Intracellular Quantitative Protein and Gene Expression Modifications and the in Vivo Effect of This Agent on the Differentiation of AML Blasts [ Time Frame: Baseline; days 3, 4, 8, and 29 of course 1; and day 29 of courses 3, 6, 9, and 12 ] [ Designated as safety issue: No ]
|Study Start Date:||July 2010|
|Study Completion Date:||March 2012|
|Primary Completion Date:||March 2012 (Final data collection date for primary outcome measure)|
Erlotinib will be administered orally at 150 mg once a day, continuously. Each cycle will be 28 days and there will be no break between the cycles.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01174043
|United States, Indiana|
|Indiana University Melvin and Bren Simon Cancer Center|
|Indianapolis, Indiana, United States, 46202|
|Principal Investigator:||S. Hamid Sayar, MD||Indiana University Melvin and Bren Simon Cancer Center|