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

March 1, 2018 updated by: Goetz Kloecker, University of Louisville

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • James Graham Brown Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • Procrit®; Ferrlecit®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Nine weeks, after at least two doses of 120,000 units epoetin alfa

Secondary Outcome Measures

Outcome Measure
Time Frame
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
Patient follow up until week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Louisville

Collaborators

James Graham Brown Cancer Center

Investigators

  • Principal Investigator: Goetz H Kloecker, MD, James Graham Brown Cancer Center, Univeristy of Louisville

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2007

Primary Completion (Actual)

November 1, 2009

Study Completion (Actual)

November 1, 2009

Study Registration Dates

First Submitted

June 1, 2007

First Submitted That Met QC Criteria

June 1, 2007

First Posted (Estimate)

June 4, 2007

Study Record Updates

Last Update Posted (Actual)

March 5, 2018

Last Update Submitted That Met QC Criteria

March 1, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 07.0210

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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