Epoetin Alfa or Epoetin Beta With or Without Iron Infusion in Treating Anemia in Patients With Cancer

January 9, 2014 updated by: St. Bartholomew's Hospital

Randomized Controlled Study of Iron Supplementation to Support the Response to Recombinant Human Erythropoietin for the Treatment of Chemotherapy-Induced Anaemia

RATIONALE: Epoetin alfa and epoetin beta may cause the body to make more red blood cells. Red blood cells contain iron that is needed to carry oxygen to the tissues. It is not yet known whether epoetin alfa or epoetin beta are more effective when given with or without iron infusion in treating anemia in patients with cancer.

PURPOSE: This randomized phase III trial is studying epoetin alfa or epoetin beta to compare how well they work with or without iron infusion in treating anemia in patients with cancer.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

  • Compare the efficacy of recombinant epoetin alfa or epoetin beta with vs without parenteral iron in anemic, iron-replete patients with nonmyeloid malignancies.

OUTLINE: This is a randomized, controlled, open-label, prospective study. Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive recombinant erythropoietic stimulatory activity (ESA) therapy comprising epoetin alfa or epoetin beta subcutaneously (SC) on day 1.
  • Arm II: Patients receive ESA therapy as in arm I and parenteral iron (i.e., low molecular weight iron dextran complex IV over 5-10 minutes or iron sucrose injection IV over 10-30 minutes) on day 1.

In both arms, treatment repeats weekly for up to 10 weeks or until hemoglobin reaches 13 g/dL, whichever comes first.

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Phase 3

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 Kingdom
    • England
      • London, England, United Kingdom, EC1A 7BE
        • Saint Bartholomew's Hospital

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

16 years and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

DISEASE CHARACTERISTICS:

  • Diagnosis of nonmyeloid malignancy

    • No primary bone marrow malignancies except multiple myeloma, chronic lymphocytic leukemia, or indolent non-Hodgkin lymphoma

  • Candidate for erythropoietin stimulatory activity therapy for anemia due to cancer and/or chemotherapy

    • Baseline hemoglobin ≤ 10.5 g/dL
    • Planning to receive ≥ 6 additional weeks of chemotherapy for the malignancy

  • Demonstrates iron-replete status as defined by all of the following parameters:

    • Percent saturation of transferrin ≥ 20%
    • Serum ferritin 225-2,250 pmol/L
    • Reticulocyte hemoglobin content > 31 pg
    • Zinc protoporphyrin < 80 µg/dL
  • No anemia of origin other than cancer or cancer chemotherapy

PATIENT CHARACTERISTICS:

  • ECOG performance status 0-2
  • No allergy or intolerance to recombinant epoetin alfa or epoetin beta
  • No known sensitivity to iron sucrose injection or iron dextran complex
  • No uncontrolled hypertension
  • No active infection
  • No active bleeding

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • No prior iron sucrose injection or iron dextran complex therapy
  • More than 6 months since prior and no concurrent transfusion

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: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Maximum hemoglobin achieved

Secondary Outcome Measures

Outcome Measure
Time to zenith hemoglobin or achievement of hemoglobin level ≥ 13 g/dL

Collaborators and Investigators

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

Sponsor

St. Bartholomew's Hospital

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

January 1, 2007

Study Registration Dates

First Submitted

June 4, 2007

First Submitted That Met QC Criteria

June 4, 2007

First Posted (ESTIMATE)

June 5, 2007

Study Record Updates

Last Update Posted (ESTIMATE)

January 10, 2014

Last Update Submitted That Met QC Criteria

January 9, 2014

Last Verified

August 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000549549
  • BARTS-06/Q0605/93
  • ISRCTN11830961
  • EU-20731

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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