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

This study has been terminated.

First Received: May 24, 2004 Last Updated: June 23, 2005 History of Changes

Sponsor:	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

Study Type:	Interventional
Study Design:	Treatment

Resource links provided by NLM:

MedlinePlus related topics: Anemia Cancer

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 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

No publications provided

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

Additional relevant MeSH terms:

Epoetin Alfa
Hematinics
Hematologic Diseases
Therapeutic Uses

Hematologic Agents
Anemia
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 09, 2009