Text Size

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.)
Sponsor:
Information provided by:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier:
NCT00083434
First received: May 24, 2004
Last updated: April 25, 2011
Last verified: April 2011
History of Changes
  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 3

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Primary Purpose: Treatment

Resource links provided by NLM:

MedlinePlus related topics: Anemia Cancer
U.S. FDA Resources

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

Study Start Date: February 2004
Study Completion Date: October 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
Advanced Urology Medical Center
Anaheim, California, United States, 92801
Shapiro, Stafford & Yee
Arcadia, California, United States, 91007
California Cancer Center
Fresno, California, United States, 93720
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

Additional 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

No publications provided

ClinicalTrials.gov Identifier: NCT00083434     History of Changes
Other Study ID Numbers: CR010549, EPO-CAN-303
Study First Received: May 24, 2004
Last Updated: April 25, 2011
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Anemia
Hematologic Diseases
Epoetin Alfa
Hematinics
 Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013