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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


Phase 2
18 Years
N/A
Not Enrolling
Both
Myelogenous Leukemia, Acute

Thank you

Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

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

Outcome Time Frame:

TBD

Safety Issue:

No

Principal Investigator

Daniel J DeAngelo, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dana-Farber Cancer Institute

Authority:

United States: Institutional Review Board

Study ID:

05-086

NCT ID:

NCT00130702

Start Date:

August 2005

Completion Date:

November 2007

Related Keywords:

  • Myelogenous Leukemia, Acute
  • AML
  • acute myelogenous leukemia
  • gefitinib
  • Iressa
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid
  • Acute Disease

Name

Location

Dana-Farber Cancer InstituteBoston, Massachusetts  02115