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

Phase 2

Completed

• Conditions: Myelogenous Leukemia, Acute
• Interventions: Drug: gefitinib

• Registration Number: NCT00130702
• Lead Sponsor: Dana-Farber Cancer Institute

Brief Summary

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

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.

Study Timeline

• Study Start: 2005-08
• Study First Submitted: 2005-08-15
• Study First Submitted QC: 2005-08-15
• Study First Posted: 2005-08-16
• Primary Completion: 2007-11
• Study Completion: 2007-11
• Status Verified: 2014-04
• Last Update Submitted: 2014-04-29
• Last Update Posted: 2014-05-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Gefitinib (Iressa)	gefitinib	All patients will receive Gefitinib (Iressa) at a dose of 750 mg orally (three 250 mg tabs) each day.

Primary Outcome Measures

Name	Time	Method
To determine the response rate of Iressa in patients with acute myelogenous leukemia

Secondary Outcome Measures

Name	Time	Method
to determine the biologic activity of Iressa in patients with acute myelogenous leukemia	2 years
To determine the safety of Iressa in patients with acute myelogenous leukemia	2 years

Trial Locations

Locations (1)

Dana-Farber Cancer Institute; 🇺🇸 Boston, Massachusetts, United States