Phase II Study Evaluating the Role of Erlotinib an Epidermal Growth Factor Receptor (EGFR) Inhibitor in the Treatment of Myelodysplastic Syndrome
Screening Period: Informed consent, physical examination, medical history report, blood
tests, pregnancy test (if applicable), list of current medications, description of symptoms,
chest x-ray, ECG, bone marrow aspirate/biopsy within 4 weeks of study start.
Weeks 2,6,10 and 14: Blood tests.
Weeks 4 and 12: Blood tests, physical exam, patients will answer question about how they are
feeling and if there are any changes to medication they have taken.
Weeks 8 and 16: Blood tests, physical exam, patients will answer question about how they are
feeling and if there are any changes to medication they have taken, bone marrow
aspirate/biopsy (if physician has determined the patient has had a clinical response or
partial response to treatment.
After week 16 (if responding to treatment): Have a bone marrow aspirate/biopsy (will be
repeated at time of relapse, i.e., more than 50% increase in the percentage of myeloblasts
[leukemia cells] or drop in blood counts after they improved or requiring regular blood
transfusions after not requiring them for at least 8 weeks,or after 1 year in study).
After the patient has stopped taking erlotinib: Periodic follow-up on patients' status.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Number of Participants With Overall Response (OR)
To test whether Erlotinib is sufficiently effective in the treatment of myelodysplastic syndrome (MDS) to warrant further investigation. The primary measure of effectiveness is the overall response rate using International working group criteria (IWG).
Rami Komrokji, M.D.
H. Lee Moffitt Cancer Center and Research Institute
United States: Institutional Review Board
|H. Lee Moffitt Cancer Center & Research Institute||Tampa, Florida 33612|