Myelodysplastic Syndrome Clinical Trial
Official title:
A Pilot Phase II Study of Erlotinib for the Treatment of Patients With Refractory/Relapsed AML
This pilot phase II trial studies how well erlotinib hydrochloride works in treating patients with relapsed or refractory acute myeloid leukemia. Erlotinib hydrochloride may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
PRIMARY OBJECTIVES:
I. To assess the efficacy of erlotinib (erlotinib hydrochloride) in patients with refractory
or relapsed acute myeloid leukemia (AML).
II. To determine the safety and tolerability of erlotinib in this patient population.
SECONDARY OBJECTIVES:
I. To investigate inhibitory effect of this drug on spleen tyrosine kinase (SYK) and its
down-stream targets such as mitogen-activated protein kinase 8 (JNK), mitogen-activated
protein kinase (MAPK) and mitogen-activated protein kinase 1 (Erk).
II. To evaluate its role in janus kinase (Jak)/signal transducer and activator of
transcription (STAT) pathway and to investigate erlotinib-mediated cell death and/or
differentiation.
III. To quantitate concentrations of plasma erlotinib.
OUTLINE:
Patients receive erlotinib hydrochloride orally (PO) once daily (QD) on days 1-28. Courses
repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 30 days.
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