Clinical trial NCT01174043: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Leukemia, Myelomonocytic, Acute
Keywords: Leukemia, Myelomonocytic, Acute
Erlotinib
Lead sponsor: Indiana University
Sponsor class: OTHER
Collaborators: name: OSI Pharmaceuticals
First posted: 2010-08-03
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Overall Response Rate (Defined as Partial Remission or Better) to 3 Months of Treatment With Erlotinib
timeFrame: 3 months of treatment with erlotinib
Secondary outcomes:
measure: Duration of Response (up to One Year Follow up) in Patients Who Achieve a Complete Remission
timeFrame: 1 year after treatment discontinuation
measure: Treatment Related Adverse Events Grade 3 or Higher
timeFrame: up to 15 months
Other outcomes:
measure: 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
timeFrame: Baseline; days 3, 4, 8, and 29 of course 1; and day 29 of courses 3, 6, 9, and 12
Locations:
city: Indianapolis
country: United States
facility: Indiana University Melvin and Bren Simon Cancer Center
state: Indiana
Study officials:
affiliation: Indiana University Melvin and Bren Simon Cancer Center
name: S. Hamid Sayar, MD
role: PRINCIPAL_INVESTIGATOR
References: