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

This study has been withdrawn prior to enrollment.
(The study was stopped because of lack of funding.)
Sponsor:
Collaborator:
University of Louisville
Information provided by (Responsible Party):
James Graham Brown Cancer Center
ClinicalTrials.gov Identifier:
NCT00481624
First received: June 1, 2007
Last updated: May 14, 2013
Last verified: May 2013
  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
Anemia
Drug: Epoetin Alfa plus Iron
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


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 ]

Enrollment: 0
Study Start Date: May 2007
Study Completion Date: November 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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®

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 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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
University of Louisville
Investigators
Principal Investigator: Goetz H Kloecker, MD James Graham Brown Cancer Center, Univeristy of Louisville
  More Information

Additional Information:
No publications provided

Responsible Party: James Graham Brown Cancer Center
ClinicalTrials.gov Identifier: NCT00481624     History of Changes
Other Study ID Numbers: 07.0210
Study First Received: June 1, 2007
Last Updated: May 14, 2013
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

Additional relevant MeSH terms:
Anemia
Lung Neoplasms
Hematologic Diseases
Lung Diseases
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Epoetin alfa
Iron
Growth Substances
Hematinics
Hematologic Agents
Micronutrients
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses
Trace Elements

ClinicalTrials.gov processed this record on October 23, 2014