Trial record 18 of 398 for:    Louisville AND Brown

Using Iron With Procrit in Advanced Lung Cancer Patients With Chemotherapy-Induced Anemia (Procrit)

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. Identifier: NCT00481624
Recruitment Status : Withdrawn (The study was stopped because of lack of funding.)
First Posted : June 4, 2007
Last Update Posted : March 5, 2018
James Graham Brown Cancer Center
Information provided by (Responsible Party):
Goetz Kloecker, University of Louisville

Brief Summary:
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 or disease Intervention/treatment Phase
Anemia Drug: Epoetin Alfa plus Iron Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : May 2007
Actual Primary Completion Date : November 2009
Actual Study Completion Date : November 2009

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Epoetin Alfa plus Iron 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.

Other Name: Procrit®; Ferrlecit®

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

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 identifier (NCT number): NCT00481624

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

Additional Information:
Responsible Party: Goetz Kloecker, Associate Professor, University of Louisville Identifier: NCT00481624     History of Changes
Other Study ID Numbers: 07.0210
First Posted: June 4, 2007    Key Record Dates
Last Update Posted: March 5, 2018
Last Verified: March 2018

Keywords provided by Goetz Kloecker, University of Louisville:
advanced lung cancer
Epoetin Alfa
Ferric Gluconate
iron supplementation

Additional relevant MeSH terms:
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Hematologic Diseases
Ferric gluconate
Epoetin Alfa
Trace Elements
Growth Substances
Physiological Effects of Drugs