Effect of Iron Therapy as an Adjunct to Epoetin Alfa in the Anemia of Cancer Chemotherapy

February 29, 2012 updated by: Watson Pharmaceuticals

A Multicenter, Randomized, Controlled Prospective Trial of the Safety and Efficacy of Ferrlecit® in Anemic Cancer Patients Who Are Receiving Acute Chemotherapy and Epoetin as Compared to Oral Iron and No Treatment

This study evaluates the safety and efficacy of Ferrlecit® (ferric gluconate; a form of intravenous iron) or ferrous sulfate (a form of oral iron) in improving the response to epoetin alfa among anemic cancer patients receiving chemotherapy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

180

Phase

  • Phase 4

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
    • California
      • Bakersfield, California, United States
      • Chula Vista, California, United States
      • Long Beach, California, United States
      • Los Angeles, California, United States
    • Connecticut
      • Norwich, Connecticut, United States
    • Florida
      • Port St Lucie, Florida, United States
      • Zephyrhills, Florida, United States
    • Georgia
      • Columbus, Georgia, United States
    • Idaho
      • Coeur d'Alene, Idaho, United States
    • Kansas
      • Hutchinson, Kansas, United States
    • Kentucky
      • Lexington, Kentucky, United States
    • Louisiana
      • Baton Rouge, Louisiana, United States
    • Maryland
      • Baltimore, Maryland, United States
    • Michigan
      • Detroit, Michigan, United States
      • Southfield, Michigan, United States
      • St Joseph, Michigan, United States
    • Minnesota
      • Duluth, Minnesota, United States
    • Mississippi
      • Greenwood, Mississippi, United States
    • New Jersey
      • Cherry Hill, New Jersey, United States
      • Denville, New Jersey, United States
    • New York
      • Manhasset, New York, United States
    • North Dakota
      • Bismarck, North Dakota, United States
    • Ohio
      • Columbus, Ohio, United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States
      • Pittsburgh, Pennsylvania, United States
      • West Chester, Pennsylvania, United States
    • South Carolina
      • Columbia, South Carolina, United States
    • Texas
      • Laredo, Texas, United States
    • Virginia
      • Richmond, Virginia, United States
      • Salem, Virginia, United States
    • Washington
      • Walla Walla, Washington, United States
    • Wisconsin
      • Milwaukee, Wisconsin, United States

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:

  • Diagnosis of nonmyeloid malignancy
  • Moderate to severe anemia
  • Adequate iron stores as measured by either TSAT or ferritin
  • About to start cycle of chemotherapy
  • Eligible for epoetin alfa therapy

Exclusion Criteria:

  • Highly elevated TSAT or ferritin
  • Recent transfusion, epoetin alfa, darbepoetin or intravenous iron
  • Medical conditions that would confound the efficacy evaluation

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Change in hemoglobin

Secondary Outcome Measures

Outcome Measure
Change in various iron indices

Collaborators and Investigators

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

Sponsor

Watson Pharmaceuticals

Investigators

  • Study Director: Naomi V. Dahl, Pharm.D., Watson Laboratories, Inc.

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.

General Publications

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, 2002

Primary Completion (Actual)

December 1, 2003

Study Completion (Actual)

December 1, 2003

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 13, 2005

First Posted (Estimate)

September 22, 2005

Study Record Updates

Last Update Posted (Estimate)

March 2, 2012

Last Update Submitted That Met QC Criteria

February 29, 2012

Last Verified

February 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FR01008

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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