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A Phase II Trial Using Intravenous Iron in Advanced Lung Cancer Patients With Chemotherapy-Induced Anemia Treated With 120,000 Units Epoetin Alfa Every Three Weeks


Phase 2
18 Years
N/A
Not Enrolling
Both
Anemia

Thank you

Trial Information

A Phase II Trial Using Intravenous Iron in Advanced Lung Cancer Patients With Chemotherapy-Induced Anemia Treated With 120,000 Units Epoetin Alfa Every Three Weeks


There are more than 170,000 patients diagnosed with lung cancer in the United States each
year and many will develop anemia (iron deficiency) during the course of treatment. Anemia
is associated with poor quality of life and treatment delays for advanced lung cancer. The
treatment of iron deficiency anemia is with iron. Iron is an essential mineral used in red
blood cells to carry oxygen throughout the body. Iron is necessary to make hemoglobin, a key
element in red blood cells.

The FDA has approved Procrit® (epoetin alfa) to treat anemia in people with non-myeloid
(bone marrow) malignancies. Procrit® is a man-made, injectable drug for treating anemia and
it encourages red cell production. While the administration of intravenous iron therapy,
injected into veins through an IV, did increase the response rate of Procrit® in a previous
study, researchers want to find out the best amount of drug to use and the best time to
administer Procrit®, along with ferric gluconate, (Ferrlecit®), added for lack of iron.


Inclusion Criteria:



- Histologically confirmed small cell or non small cell lung cancer

- Stage III or Stage IV lung cancer

- Platinum containing chemotherapy induced anemia (< 10 g/dl Hb)

- Cancer related anemia (<10 g/dl Hb) at time of initiation of chemotherapy

- ECOG performance status of 0,1, or 2

- Informed consent

- Age>18

- Expected to receive platinum based outpatient chemotherapy for at least nine weeks

Exclusion Criteria:

- Pregnant women

- Intolerance to epoetin alfa or parenteral iron

- More than 2 cycles of the planned platinum chemotherapy at time of enrollment

- Chronic GI bleed (> than 4 weeks positive hemoccult or gastroccult)

- Ferritin > 500 mg/dl

- Anemia due to other causes than cancer or chemotherapy

- Previous parenteral iron therapy

- Uncontrolled hypertension (systolic BP > 160, diastolic > 100 mmHg)

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:

Achieve hemoglobin responses > 2g/dl in at least 70% of patients

Outcome Time Frame:

Nine weeks, after at least two doses of 120,000 units epoetin alfa

Safety Issue:

No

Principal Investigator

Goetz H Kloecker, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

James Graham Brown Cancer Center, Univeristy of Louisville

Authority:

United States: Institutional Review Board

Study ID:

07.0210

NCT ID:

NCT00481624

Start Date:

May 2007

Completion Date:

November 2009

Related Keywords:

  • Anemia
  • advanced lung cancer
  • Procrit
  • Epoetin Alfa
  • Ferric Gluconate
  • iron supplementation
  • Anemia
  • Lung Neoplasms

Name

Location

James Graham Brown Cancer CenterLouisville, Kentucky  40202