Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Using Iron With Procrit in Advanced Lung Cancer Patients With Chemotherapy-Induced Anemia
This study has been suspended.
Sponsored by: James Graham Brown Cancer Center
Information provided by: James Graham Brown Cancer Center
ClinicalTrials.gov Identifier: NCT00481624
  Purpose

The purpose of this study is to find a better, more convenient way to improve anemia results by increasing the amount of medication given at 3 week intervals. Researchers want to know if giving a higher dose of Procrit® and intravenous (IV) iron once every 3 weeks would give better results in treating anemia without the need for more office visits.


Condition Intervention Phase
Advanced Lung Cancer
Chemotherapy Induced Anemia
Drug: Epoetin Alfa plus Iron
Phase II

MedlinePlus related topics: Anemia Cancer Lung Cancer
Drug Information available for: Epoetin alfa Erythropoietin Sodium ferric gluconate complex D-Gluconic acid, monosodium salt Gluconic acid Manganese gluconate
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 Trial Using Intravenous Iron in Advanced Lung Cancer Patients With Chemotherapy-Induced Anemia Treated With 120,000 Units Epoetin Alfa Every Three Weeks

Further study details as provided by James Graham Brown Cancer Center:

Primary Outcome Measures:
  • Achieve hemoglobin responses > 2g/dl in at least 70% of patients [ Time Frame: Nine weeks, after at least two doses of 120,000 units epoetin alfa ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Descriptive evaluation of adverse effects of parenteral iron and epoetin alfa 120,000 units given every three weeks [ Time Frame: Patient follow up until week 12 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 25
Study Start Date: May 2007
Estimated Study Completion Date: June 2010
Estimated Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Epoetin Alfa plus Iron
    1. One (1) injection of Procrit®, by needle, inserted just under the skin;
    2. 125 mg of ferric gluconate (an iron injection product), through an IV injection into a vein.

    These injections will take approximately 10-15 minutes to complete. Both will be administered every 3 weeks for a total of 4 cycles, unless the study doctor decides that a change in the amount of Procrit® and iron is necessary once the hemoglobin level rises or is above a certain amount.

    In addition to Procrit® and the intravenous iron, the subject will also receive platinum-containing chemotherapy every 3 weeks for 4 cycles as per standard of care for their lung cancer treatment. Radiation therapy will be allowed during this regimen if it is part of the subject's treatment plan.

Detailed Description:

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.

  Eligibility

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

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 hemoccults or gastroccults)
  • 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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00481624

Locations
United States, Kentucky
James Graham Brown Cancer Center
Louisville, Kentucky, United States, 40202
Sponsors and Collaborators
James Graham Brown Cancer Center
Investigators
Principal Investigator: Goetz H Kloecker, MD James Graham Brown Cancer Center, Univeristy of Louisville
  More Information

James Graham Brown Cancer Center, Louisville, KY  This link exits the ClinicalTrials.gov site

Responsible Party: James Graham Brown Cancer Center ( Goetz H. Kloecker, MD )
Study ID Numbers: 210.07
Study First Received: June 1, 2007
Last Updated: August 15, 2008
ClinicalTrials.gov Identifier: NCT00481624  
Health Authority: United States: Institutional Review Board

Keywords provided by James Graham Brown Cancer Center:
advanced lung cancer
Procrit
Epoetin Alfa
Ferric Gluconate
iron supplementation

Study placed in the following topic categories:
Epoetin Alfa
Thoracic Neoplasms
Respiratory Tract Diseases
Hematologic Diseases
Lung Neoplasms
Lung Diseases
Ferric gluconate
Anemia
Iron

Additional relevant MeSH terms:
Respiratory Tract Neoplasms
Neoplasms
Neoplasms by Site
Hematinics
Growth Substances
Therapeutic Uses
Physiological Effects of Drugs
Hematologic Agents
Trace Elements
Micronutrients
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 13, 2009