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

This study has been completed.

Sponsor:

Collaborators:

Brigham and Women's Hospital

Children's Hospital Boston

Information provided by:

Dana-Farber Cancer Institute

ClinicalTrials.gov Identifier:

NCT00130702

First received: August 15, 2005

Last updated: March 9, 2011

Last verified: March 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

August 15, 2005

Last Updated Date

March 9, 2011

Start Date ^ICMJE

August 2005

Primary Completion Date

November 2007 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

To determine the response rate of Iressa in patients with Acute Myelogenous Leukemia.

Change History

Complete list of historical versions of study NCT00130702 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

To determine the safety of Iressa in patients with acute myelogenous leukemia
to determine the biologic activity of Iressa in patients with acute myelogenous leukemia

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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 Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Myelogenous Leukemia, Acute

Intervention ^ICMJE

Drug: gefitinib

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

Other Name: Iressa

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

Completion Date

November 2007

Primary Completion Date

November 2007 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00130702

Other Study ID Numbers ^ICMJE

05-086

Has Data Monitoring Committee

Responsible Party

Daniel DeAngelo, MD, PhD, Dana-Farber Cancer Institute

Study Sponsor ^ICMJE

Dana-Farber Cancer Institute

Collaborators ^ICMJE

Brigham and Women's Hospital
Children's Hospital Boston

Investigators ^ICMJE

Principal Investigator:

Daniel J DeAngelo, MD, PhD

Dana-Farber Cancer Institute

Information Provided By

Dana-Farber Cancer Institute

Verification Date

March 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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