Status:
COMPLETED
Pilot Study of Erlotinib for the Treatment of Patients With de Novo Acute Myeloid Leukemia
Lead Sponsor:
Indiana University
Collaborating Sponsors:
OSI Pharmaceuticals
Conditions:
Leukemia, Myelomonocytic, Acute
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 cer...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2012
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT01174043
Start Date
July 1 2010
End Date
March 1 2012
Last Update
October 13 2023
Active Locations (1)
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1
Indiana University Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, United States, 46202