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

NCT01174043 | Completed Phase 2 Results DMC

• 1 other identifier: 1006-12; IUCRO-0300
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Leukemia, Myelomonocytic, Acute

Keywords

Leukemia, Myelomonocytic, Acute; Erlotinib

Outcome Measures

Primary Outcomes (1)

• Overall Response Rate (Defined as Partial Remission or Better) to 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.

  3 months of treatment with erlotinib

Secondary Outcomes (2)

• Duration of Response (up to One Year Follow up) in Patients Who Achieve a Complete Remission

  1 year after treatment discontinuation

• Treatment Related Adverse Events Grade 3 or Higher

  up to 15 months

Other Outcomes (1)

• 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

  Baseline; days 3, 4, 8, and 29 of course 1; and day 29 of courses 3, 6, 9, and 12

Study Arms (1)

Erlotinib

EXPERIMENTAL

Drug: Erlotinib

Interventions

Erlotinib DRUG

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.

Erlotinib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Indiana University: lead
• OSI Pharmaceuticals: collaborator

Study Sites (1)

Indiana University Melvin and Bren Simon Cancer Center

Indianapolis, Indiana, 46202, United States

Location

MeSH Terms

Conditions

Leukemia, Myelomonocytic, Acute

Interventions

Erlotinib Hydrochloride

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Dr. Hamid Sayar
• Organization: IndianaU

ssayar@iu.edu

(317)278-6871

Study Officials

• S. Hamid Sayar, MD

  Indiana University Melvin and Bren Simon Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2010
• First Posted: August 3, 2010
• Study Start: July 1, 2010
• Primary Completion: March 1, 2012
• Study Completion: March 1, 2012
• Last Updated: October 13, 2023
• Results First Posted: March 27, 2015

Record last verified: 2023-10

Locations

US (1)