A Study of the Safety and Effectiveness of Epoetin Alfa on Hemoglobin Levels and Blood Transfusions in Cancer Patients Receiving Chemotherapy

• Status: Completed
• Trial end date: 2006-09-01
• Target enrollment: 0
• Participant gender: All

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 cancer patients receiving chemotherapy as compared to patients receiving standard epoetin alfa treatment and best standard of care.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Janssen-Cilag B.V.
• Treatments: Epoetin Alfa

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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