Treatment of Anemia in Patients With Cancer Who Are Not Currently Receiving Chemotherapy or Radiotherapy

April 25, 2011 updated by: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
The purpose of this study is to determine the effectiveness of different doses of epoetin alfa for treating anemia in patients who have cancer; or patients who no longer have any signs of cancer, but remain anemic as a result of their treatment. These patients should not be currently receiving chemotherapy or radiotherapy. A subject's participation in the study will last approximately 6 months. Subjects will receive weekly doses of epoetin alfa or placebo. Their hemoglobin will be tested every week.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

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 States
    • Arkansas
      • Hot Springs, Arkansas, United States, 71913
        • Heritage Physician Group-Oncology
    • Georgia
      • Griffin, Georgia, United States, 30224
        • Spalding Oncology Services
    • Illinois
      • Centralia, Illinois, United States, 62801
        • Southern Illinois Hematology
    • Maryland
      • Rockville, Maryland, United States, 20852
        • BioLab Research
    • New York
      • New Hartford, New York, United States, 13413
        • Slocum-Dickson Medical Group, PC
    • North Carolina
      • Concord, North Carolina, United States
        • Northeast Urology Research
    • Ohio
      • Columbus, Ohio, United States, 43213
        • Mid Ohio Oncology Hematology
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19102
        • Drexel University College of Medicine
    • South Carolina
      • Aiken, South Carolina, United States, 29403
        • Caroline Cancer Center
      • Charleston, South Carolina, United States, 29403
        • Charleston Hematology Oncology
      • Charleston, South Carolina, United States, 29406
        • Charleston Cancer Care
    • Tennessee
      • Knoxville, Tennessee, United States, 37920
        • Volunteer Research Group

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:

  • Body weight >/=99 lbs
  • ECOG 0-2
  • Anemia results from cancer, chemotherapy, radiotherapy or an association with hormonal therapy or immunotherapy
  • Screening hemoglobin level of </=11.0 g/dL for men or </=10.0 for women

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

Collaborators and Investigators

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

Sponsor

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

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

February 1, 2004

Study Completion (Actual)

October 1, 2004

Study Registration Dates

First Submitted

May 24, 2004

First Submitted That Met QC Criteria

May 26, 2004

First Posted (Estimate)

May 27, 2004

Study Record Updates

Last Update Posted (Estimate)

April 27, 2011

Last Update Submitted That Met QC Criteria

April 25, 2011

Last Verified

April 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR010939
  • EPO-CAN-203

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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