Trial of Erlotinib in Patients With JAK-2 V617F Positive Polycythemia Vera

This is a phase II open-label study. Patients will be screened for MPN diagnoses and patients
with Polycythemia vera proven to have JAK2V617F mutation will be given the option to enroll.
Consenting patients will take erlotinib daily for 16 weeks. Blood work and pharmacokinetics
will be drawn for serum level monitoring. Doses will be administered according to side
effects or held. First assessment will be at day 15 wth subsequent assessments at 28 day
intervals. Non-responders will be taken off the study and managed according to standard of
care. Patients who do respond will continue taking the therapy for a total of 12 months.
Observation will be for a total of 12 months after finishing treatment. In addition to the
clinical aspect of this study, there will be correlative studies where molecular response
will be checked and its correlation with clinical response.

Inclusion Criteria:

- WHO 2008 diagnosis of Polycythemia Vera Hemoglobin > 18.5 g/dl for men (16.5 g/dl for
women) and presence of JAK2V617F mutation and either bone marrow trilineage
myeloproliferation or subnormal serum erythropoietin level Patients may be on active
treatment (phlebotomy, aspirin) ECOG performance status 0,1,2,or 3 Adequate hepatic
function, adequate renal function

Exclusion Criteria:

- Patient with active malignancy Patients with clinically significant cardiac disease
within 1 year Opthalmologic or gastrointestinal abnormalities Concurrent cytoreductive
therapy is not allowed