Study of Iressa in Patients With Relapsed or Refractory Acute Myelogenous Leukemia - Full Text View

Sponsors and Collaborators:	Dana-Farber Cancer Institute Brigham and Women's Hospital Children's Hospital Boston
Information provided by:	Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:	NCT00130702

Purpose

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

Condition	Intervention	Phase
Myelogenous Leukemia, Acute	Drug: gefitinib	Phase II

MedlinePlus related topics: Cancer Leukemia, Adult Acute Leukemia, Adult Chronic

Drug Information available for: ZD1839

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
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

Further study details as provided by Dana-Farber Cancer Institute:

Primary Outcome Measures:

To determine the response rate of Iressa in patients with acute myelogenous leukemia [ Time Frame: TBD ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	40
Study Start Date:	August 2005
Estimated Study Completion Date:	November 2010
Primary Completion Date:	November 2007 (Final data collection date for primary outcome measure)

Intervention Details:

gefitinib (Iressa) at a dose of 750 mg, once per day

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00130702

Locations

United States, Massachusetts
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115

Sponsors and Collaborators

Dana-Farber Cancer Institute

Brigham and Women's Hospital

Children's Hospital Boston

Investigators

Principal Investigator:

Daniel J DeAngelo, MD, PhD

Dana-Farber Cancer Institute

More Information

Responsible Party:	Dana-Farber Cancer Institute ( Daniel DeAngelo, MD, PhD )
Study ID Numbers:	05-086
Study First Received:	August 15, 2005
Last Updated:	January 6, 2009
ClinicalTrials.gov Identifier:	NCT00130702
Health Authority:	United States: Institutional Review Board

Keywords provided by Dana-Farber Cancer Institute:

AML
acute myelogenous leukemia
gefitinib
Iressa

Study placed in the following topic categories:

Leukemia
Acute myelogenous leukemia
Leukemia, Myeloid

Leukemia, Myeloid, Acute
Gefitinib
Acute myelocytic leukemia

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents

Therapeutic Uses
Enzyme Inhibitors
Protein Kinase Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009