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. )

First Received: May 24, 2004 Last Updated: June 29, 2007 History of Changes

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

Study Type:	Interventional
Study Design:	Treatment, Efficacy Study

Resource links provided by NLM:

MedlinePlus related topics: Anemia Cancer Radiation Therapy

Drug Information available for: Erythropoietin Epoetin alfa

U.S. FDA Resources

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

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

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

Study ID Numbers:	EPO-CAN-303
Study First Received:	May 24, 2004
Last Updated:	June 29, 2007
ClinicalTrials.gov Identifier:	NCT00083434 History of Changes
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
Hematinics
Hematologic Diseases
Anemia

Additional relevant MeSH terms:

Epoetin Alfa
Hematinics
Hematologic Diseases
Therapeutic Uses

Hematologic Agents
Anemia
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 02, 2009