Status:
COMPLETED
A Study of the Safety and Effectiveness of Epoetin Alfa on Hemoglobin Levels and Blood Transfusions in Cancer Patients Receiving Chemotherapy
Lead Sponsor:
Janssen-Cilag B.V.
Conditions:
Anemia
Neoplasms
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The purpose of this study is to evaluate the effect of early treatment with epoetin alfa in addition to best standard of care on hemoglobin levels and the need for red blood cell transfusions in cance...
Detailed Description
Cancer patients often experience anemia due to the disease itself, chemotherapy, or both. Quality of life is also affected, due in part to the tiredness associated with anemia. Previous studies with e...
Eligibility Criteria
Inclusion
- Confirmed diagnosis of cancer and planned to receive chemotherapy in 1, 2, 3, or 4 weekly schedules for a minimum of 8 weeks
- have a hemoglobin level of \>10 grams per deciliter and \<= 12 grams per deciliter within 14 days before the start of the first on-study chemotherapy cycle
- Eastern Cooperative Oncology Group (scale used by researchers to represent the level of activity a patient is capable of) score of 0 (able to carry out all normal activity without restriction) to 2 (ambulatory and capable of all self-care but unable to carry out any work)
- life expectancy of \>=6 months
- female subjects postmenopausal for at least 1 year, surgically sterile or practicing an effective method of birth control
Exclusion
- Clinically significant or uncontrolled disease/dysfunction of any body system that is not due to cancer or chemotherapy, including uncontrolled or severe cardiovascular disease, recent (\< 6 months) myocardial infarction, uncontrolled high blood pressure, congestive heart failure, or uncontrolled or unexplained history of seizures
- planned surgery expected to influence hemoglobin levels, within the first 8 or 9 weeks of study entry
- major illness or infection within 1 month of study entry
- highly increased risk of thrombotic or other vascular events
- androgen therapy within 2 months of study entry
- anemia due to factors other than cancer/chemotherapy (e.g., severe hemolysis, gastrointestinal bleeding, or myelodysplastic syndromes)
- blood transfusion within 14 days prior to study entry
- pregnant or lactating females
Key Trial Info
Start Date :
August 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2006
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT00216541
Start Date
August 1 2003
End Date
September 1 2006
Last Update
May 19 2011
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