Expired Study
This study is not currently recruiting Study Participants on ClinicalConnection.com. If you would like to find active studies please search for clinical trials.

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.


NCT ID:

NCT01174043


Primary Contact:

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


Backup Contact:

N/A


Location Contact:

Indianapolis, Indiana 46202
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: August 31, 2019

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


Click to view Full Listing

This study is not currently recruiting Study Participants on ClinicalConnection.com. The form below is not enabled.