Erlotinib Study for Myelodysplastic Syndrome (MDS)
The purpose of this research study is to find out what effects, good and/or bad, erlotinib has on the patient and their myelodysplastic syndrome. Erlotinib has been approved by the Food and Drug Administration (FDA) to treat non-small cell lung cancer; however, erlotinib use in this study is considered investigational as the FDA has not approved it for the treatment of myelodysplastic syndrome.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Study Evaluating the Role of Erlotinib an Epidermal Growth Factor Receptor (EGFR) Inhibitor in the Treatment of Myelodysplastic Syndrome|
- Number of Participants With Overall Response (OR) [ Time Frame: 21 Months ] [ Designated as safety issue: Yes ]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).
- Number of Participants With Overall Survival (OS) [ Time Frame: 21 Months ] [ Designated as safety issue: No ]Kaplan-Meier estimates will be used for those secondary endpoints analysis.
|Study Start Date:||September 2009|
|Study Completion Date:||June 2012|
|Primary Completion Date:||June 2012 (Final data collection date for primary outcome measure)|
Patients will take 150 mg of erlotinib by mouth every day while on study. Patients will take erlotinib at least 1 hour before or 2 hours after they eat a meal or snack. To help patients to remember to take erlotinib, they are advised to take it at around the same time every day.
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.
|United States, Florida|
|H. Lee Moffitt Cancer Center & Research Institute|
|Tampa, Florida, United States, 33612|
|Principal Investigator:||Rami Komrokji, M.D.||H. Lee Moffitt Cancer Center and Research Institute|