- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00083434
Treatment of Anemic Patients With Cancer Who Are Not Receiving Chemotherapy or Radiotherapy
April 25, 2011 updated by: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
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.
Study Overview
Study Type
Interventional
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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California
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Anaheim, California, United States, 92801
- Advanced Urology Medical Center
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Arcadia, California, United States, 91007
- Shapiro, Stafford & Yee
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Fresno, California, United States, 93720
- California Cancer Center
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Florida
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North Miami, Florida, United States, 33161
- Tukoi Research
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North Carolina
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Wilmington, North Carolina, United States, 28401
- Hanover Medical Specialists, PA
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Washington
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Tacoma, Washington, United States, 98431-5000
- Madigan Army Medical Center Urology Services
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2004
Study Completion (Actual)
October 1, 2004
Study Registration Dates
First Submitted
May 24, 2004
First Submitted That Met QC Criteria
May 25, 2004
First Posted (Estimate)
May 26, 2004
Study Record Updates
Last Update Posted (Estimate)
April 27, 2011
Last Update Submitted That Met QC Criteria
April 25, 2011
Last Verified
April 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CR010549
- EPO-CAN-303
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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M.D. Anderson Cancer CenterCompleted
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Johnson & Johnson Pharmaceutical Research & Development...Ortho Biotech, Inc.Completed
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Johnson & Johnson Pharmaceutical Research & Development...CompletedBlood Transfusion | Orthopedic Surgery | Orthopedic Procedures | Mammaplasty | Cardiovascular Surgical Procedures | Blood Transfusion, Autologous
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Johnson & Johnson Pharmaceutical Research & Development...Ortho Biotech Products, L.P.Terminated
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Johnson & Johnson Pharmaceutical Research & Development...Completed
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Johnson & Johnson Pharmaceutical Research & Development...Completed
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Johnson & Johnson Pharmaceutical Research & Development...Ortho Biotech Products, L.P.CompletedCritical Illness | Anemia