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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:
Collaborator:
OSI Pharmaceuticals
Information provided by (Responsible Party):
Indiana University
ClinicalTrials.gov Identifier:
NCT01174043
First received: July 30, 2010
Last updated: September 19, 2014
Last verified: September 2014

July 30, 2010
September 19, 2014
July 2010
March 2012   (final data collection date for primary outcome measure)
Evaluate overall response (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 ]
Same as current
Complete list of historical versions of study NCT01174043 on ClinicalTrials.gov Archive Site
  • Evaluate the 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 ]
  • Number and grade of adverse events [ 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).
Evaluate the 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 ]
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 ]
Not Provided
 
Pilot Study of Erlotinib for the Treatment of Patients With de Novo Acute Myeloid Leukemia
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.

Not Provided
Interventional
Phase 2
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Leukemia, Myelomonocytic, Acute
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.
Experimental: Erlotinib
Intervention: Drug: Erlotinib
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
11
March 2012
March 2012   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01174043
1006-12; IUCRO-0300
Yes
Indiana University
Indiana University
OSI Pharmaceuticals
Principal Investigator: S. Hamid Sayar, MD Indiana University Melvin and Bren Simon Cancer Center
Indiana University
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP