Study of Iressa in Patients With Relapsed or Refractory Acute Myelogenous Leukemia

Study Overview
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Brief Summary
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The purpose of this study is to determine how effective, and to what extent, Iressa is in the treatment of acute myelogenous leukemia.

Detailed Description
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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.

Official Title
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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

Conditions
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Myelogenous Leukemia, Acute

Intervention / Treatment
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* Drug: gefitinib


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients must have pathologically documented acute myelogenous leukemia and either not be a candidate for myelosuppressive chemotherapy due to age or comorbid disease; or have relapsed acute myelogenous leukemia or be refractory to standard therapy and not likely to require cytoreductive therapy within 30 days. ECOG performance status 0, 1 or 2 Age > 18 years Adequate kidney and hepatic function Greater than 4 weeks from any chemotherapy, radiotherapy, immunotherapy, or systemic steroid therapy with the exception of hydroxyurea. Greater than 2 months following bone marrow or peripheral blood stem cell transplantation or donor lymphocyte infusion. Exclusion Criteria: Uncontrolled active infection Urgent need for cytoreductive chemotherapy, surgery, or radiotherapy Current chemotherapy or chemotherapy within the last 4 weeks. Pregnancy or nursing mothers Infection with HIV

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Gefitinib (Iressa)<br>All patients will receive Gefitinib (Iressa) at a dose of 750 mg orally (three 250 mg tabs) each day. | Drug: gefitinib<br>* gefitinib (Iressa) at a dose of 750 mg, once per day<br>* Other names: Iressa;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the response rate of Iressa in patients with acute myelogenous leukemia |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the safety of Iressa in patients with acute myelogenous leukemia |  | 2 years | 
| to determine the biologic activity of Iressa in patients with acute myelogenous leukemia |  | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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AML, acute myelogenous leukemia, gefitinib, Iressa