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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00130702
First Posted: August 16, 2005
Last Update Posted: May 1, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Brigham and Women's Hospital
Boston Children’s Hospital
Information provided by (Responsible Party):
Daniel J. DeAngelo, MD, PhD, Dana-Farber Cancer Institute
  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 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (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

Resource links provided by NLM:


Further study details as provided by Daniel J. DeAngelo, MD, PhD, Dana-Farber Cancer Institute:

Primary Outcome Measures:
  • To determine the response rate of Iressa in patients with acute myelogenous leukemia

Secondary Outcome Measures:
  • To determine the safety of Iressa in patients with acute myelogenous leukemia [ Time Frame: 2 years ]
  • to determine the biologic activity of Iressa in patients with acute myelogenous leukemia [ Time Frame: 2 years ]

Enrollment: 18
Study Start Date: August 2005
Study Completion Date: November 2007
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Gefitinib (Iressa)
All patients will receive Gefitinib (Iressa) at a dose of 750 mg orally (three 250 mg tabs) each day.
Drug: gefitinib
gefitinib (Iressa) at a dose of 750 mg, once per day
Other Name: Iressa

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
Boston Children’s Hospital
Investigators
Principal Investigator: Daniel J DeAngelo, MD, PhD Dana-Farber Cancer Institute
  More Information

Responsible Party: Daniel J. DeAngelo, MD, PhD, Principal Investigator, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT00130702     History of Changes
Other Study ID Numbers: 05-086
First Submitted: August 15, 2005
First Posted: August 16, 2005
Last Update Posted: May 1, 2014
Last Verified: April 2014

Keywords provided by Daniel J. DeAngelo, MD, PhD, Dana-Farber Cancer Institute:
AML
acute myelogenous leukemia
gefitinib
Iressa

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Neoplasms
Gefitinib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action