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

This study has been terminated.

Sponsored by: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Information provided by: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier: NCT00083486
  Purpose

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.


Condition Intervention Phase
Anemia
Drug: epoetin alfa
Phase III

MedlinePlus related topics:   Anemia    Cancer   

Drug Information available for:   Epoetin alfa    Erythropoietin   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment

Further study details as provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:

Study Start Date:   December 2003

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00083486

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

Sponsors and Collaborators
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
  More Information


Study ID Numbers:   EPO-CAN-203
First Received:   May 24, 2004
Last Updated:   June 23, 2005
ClinicalTrials.gov Identifier:   NCT00083486
Health Authority:   United States: Food and Drug Administration

Study placed in the following topic categories:
Epoetin Alfa
Hematologic Diseases
Anemia

Additional relevant MeSH terms:
Hematinics
Therapeutic Uses
Hematologic Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 30, 2008




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