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Treatment of Anemic Patients With Cancer Who Are Not Receiving Chemotherapy or Radiotherapy

This study has been terminated.
( This study was stopped because of an inadequate rate of enrollment. )

Sponsored by: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Information provided by: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier: NCT00083434
  Purpose

The purpose of this study is to examine the effectiveness of epoetin alfa in treating anemia in patients who have cancer or who no longer have any signs of the cancer, but remain anemic as a result of their treatment.


Condition Intervention Phase
Anemia
Cancer
Drug: Epoetin alfa
Phase III

MedlinePlus related topics:   Anemia    Cancer   

ChemIDplus related topics:   Epoetin alfa    Erythropoietin   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Efficacy Study

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

Study Completion Date:   December 2004

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

Criteria

Inclusion Criteria:

  • 18 years of age or older
  • Body weight >/= 99lbs
  • 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

Exclusion Criteria:

  • History of or concurrent second malignancy
  • Evidence of primary or metastatic malignancy involving the Central Nervous System
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00083434

Locations
United States, California
Shapiro, Stafford & Yee    
      Arcadia, California, United States, 91007
California Cancer Center    
      Fresno, California, United States, 93720
Advanced Urology Medical Center    
      Anaheim, California, United States, 92801
United States, Florida
Tukoi Research    
      North Miami, Florida, United States, 33161
United States, North Carolina
Hanover Medical Specialists, PA    
      Wilmington, North Carolina, United States, 28401
United States, Washington
Madigan Army Medical Center Urology Services    
      Tacoma, Washington, United States, 98431-5000

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

FDA Approved Product labeling, refer to the following link:http://www.accessdata.fda.gov/scripts/cder/drugsatfda/  This link exits the ClinicalTrials.gov site
 
Additional information is provided at the following link:http://dailymed.nlm.nih.gov/dailymed/about.cfm  This link exits the ClinicalTrials.gov site
 
For FDA Safety Alerts and Recalls refer to the following link:www.fda.gov/MEDWATCH/safety.htm  This link exits the ClinicalTrials.gov site
 

Study ID Numbers:   EPO-CAN-303
First Received:   May 24, 2004
Last Updated:   June 29, 2007
ClinicalTrials.gov Identifier:   NCT00083434
Health Authority:   United States: Food and Drug Administration

Keywords provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:
Anemia  
Cancer  

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 August 21, 2008




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