Expired Study
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Indianapolis, Indiana 46202


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.


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.


Study is Available At:


Original ID:

1006-12; IUCRO-0300


NCT ID:

NCT01174043


Secondary ID:


Study Acronym:


Brief Title:

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


Official Title:

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


Overall Status:

Completed


Study Phase:

Phase 2


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Indiana University


Oversight Authority:

  • United States: Institutional Review Board
  • United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Endpoint Classification: Efficacy Study, Intervent


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

11


Enrollment Type:

Actual


Overall Contact Information

Official Name:S. Hamid Sayar, MD
Principal Investigator
Indiana University Melvin and Bren Simon Cancer Center

Study Dates

Start Date:July 2010
Completion Date:March 2012
Completion Type:Actual
Primary Completion Date:March 2012
Primary Completion Type:Actual
Verification Date:September 2014
Last Changed Date:September 19, 2014
First Received Date:July 30, 2010

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Number and grade of adverse events
Time Frame:up to 15 months
Safety Issues:True
Description: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).
Outcome Type:Secondary Outcome
Measure: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
Safety Issues:False
Outcome Type: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
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:Erlotinib
Description: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.
Arm Name:Erlotinib

Study Arms

Study Arm Type:Experimental
Arm Name:Erlotinib

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Indiana University
Agency Class:Industry
Agency Type:Collaborator
Agency Name:OSI Pharmaceuticals

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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