Study of Iressa in Patients With Relapsed or Refractory Acute Myelogenous Leukemia
The purpose of this study is to determine how effective, and to what extent, Iressa is in the treatment of 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|