Study of Iressa in Patients With Relapsed or Refractory Acute Myelogenous Leukemia
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Study of Iressa (Gefitinib), in Patients With Relapsed or Refractory Acute Myelogenous Leukemia and in Older Patients With Newly Diagnosed Acute Myelogenous Leukemia|
- To determine the response rate of Iressa in patients with acute myelogenous leukemia [ Time Frame: TBD ] [ Designated as safety issue: No ]
- To determine the safety of Iressa in patients with acute myelogenous leukemia [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
- to determine the biologic activity of Iressa in patients with acute myelogenous leukemia [ Time Frame: 2 years ] [ Designated as safety issue: No ]
|Study Start Date:||August 2005|
|Study Completion Date:||November 2007|
|Primary Completion Date:||November 2007 (Final data collection date for primary outcome measure)|
Experimental: Gefitinib (Iressa)
All patients will receive Gefitinib (Iressa) at a dose of 750 mg orally (three 250 mg tabs) each day.
gefitinib (Iressa) at a dose of 750 mg, once per day
Other Name: Iressa
Patients will receive Iressa daily until either disease progression or intolerable toxicity develops. On Day 1 of treatment, a physical exam and bloodwork will be performed. Once weekly for the first 8 weeks, a physical exam and complete blood count with differential will be performed.
For the first year, a physical exam, bloodwork will be performed monthly. Bone marrow biopsies will be performed after the first month of therapy and then every 3 months for the first year. After the first year a physical exam, bloodwork will be performed every 3 months and bone marrow biopsies every 6 months.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00130702
|United States, Massachusetts|
|Dana-Farber Cancer Institute|
|Boston, Massachusetts, United States, 02115|
|Principal Investigator:||Daniel J DeAngelo, MD, PhD||Dana-Farber Cancer Institute|