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Pilot Study of Erlotinib for the Treatment of Patients With de Novo Acute Myeloid Leukemia

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01174043
First Posted: August 3, 2010
Last Update Posted: March 27, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
OSI Pharmaceuticals
Information provided by (Responsible Party):
Indiana University
  Purpose
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.

Condition Intervention Phase
Leukemia, Myelomonocytic, Acute Drug: Erlotinib Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pilot Study of Erlotinib for the Treatment of Patients With de Novo Acute Myeloid Leukemia

Resource links provided by NLM:


Further study details as provided by Indiana University:

Primary Outcome Measures:
  • Overall Response Rate (Defined as Partial Remission or Better) to 3 Months of Treatment With Erlotinib [ Time Frame: 3 months of treatment with erlotinib ]
    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.


Secondary Outcome Measures:
  • Duration of Response (up to One Year Follow up) in Patients Who Achieve a Complete Remission [ Time Frame: 1 year after treatment discontinuation ]
    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 ]
    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.


Other Outcome Measures:
  • 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 ]

Enrollment: 11
Study Start Date: July 2010
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Erlotinib Drug: Erlotinib
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of AML with no history of previous clonal/malignant hematologic disorders such as myelodysplastic syndromes or myeloproliferative disorders.
  • Newly diagnosed patients will be age 70 or older
  • Relapses patients will be age 60 or older any time following first relapse, if patient is not considered candidate/not interested in salvage chemotherapy.
  • Refractory disease patients will be age 18-59 who have failed at least 2 lines of conventional chemotherapy (1 induction and 1 salvage)
  • Patient must have discontinued all previous therapies for AML at least 14 days and recovered from the non-hematologic side effects of the therapy.
  • Laboratory tests must be within protocol-specified ranges
  • Patient must be able to swallow and tolerate oral medication.

Exclusion Criteria:

  • Patients with known central nervous system (CNS) leukemia by spinal fluid cytology, flow cytometry or imaging.
  • History of antecedent pre-leukemic hematologic disorders such as myelodysplastic syndromes or myeloproliferative disorders.
  • Diagnosis of acute promyelocytic leukemia (APL)
  • Patients who require chronic anticoagulation, are current smokers or who are taking rifabutin, rifapentine, phenytoin, carbamazepine, phenobarbital and St. John's Wort are not eligible.
  • Patients with active corneal erosions or history of abnormal corneal sensitivity test.
  • Patients with serious illness such as: significant ongoing or active infection, New York Heart Association (NYHA) Grade II or greater congestive heart failure, unstable angina (anginal symptoms at rest), new onset angina (began within the last 3 months), myocardial infarction within the past 6 months, cardiac ventricular arrhythmias requiring anti-arrhythmic therapy, cerebrovascular accident within past 3 months, or psychiatric illness that would limit compliance with the study requirements.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01174043


Locations
United States, Indiana
Indiana University Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, United States, 46202
Sponsors and Collaborators
Indiana University
OSI Pharmaceuticals
Investigators
Principal Investigator: S. Hamid Sayar, MD Indiana University Melvin and Bren Simon Cancer Center
  More Information

Responsible Party: Indiana University
ClinicalTrials.gov Identifier: NCT01174043     History of Changes
Other Study ID Numbers: 1006-12; IUCRO-0300
First Submitted: July 30, 2010
First Posted: August 3, 2010
Results First Submitted: March 18, 2015
Results First Posted: March 27, 2015
Last Update Posted: March 27, 2015
Last Verified: March 2015

Keywords provided by Indiana University:
Leukemia, Myelomonocytic, Acute
Erlotinib

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Leukemia, Myelomonocytic, Acute
Neoplasms by Histologic Type
Neoplasms
Erlotinib Hydrochloride
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action