Status:
COMPLETED
The Effect of Epoetin Alfa on the Anemia of Patients With Selected Cancers Receiving Chemotherapy
Lead Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Conditions:
Anemia
Multiple Myeloma
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to evaluate the safety and effectiveness of epoetin alfa versus placebo in reducing or preventing the need for transfusions in anemic patients with cancer receiving chemot...
Detailed Description
Cancer patients often experience anemia due to the disease itself, chemotherapy, or both. Quality of life is also affected, in part because of the fatigue associated with anemia. Previous studies with...
Eligibility Criteria
Inclusion
- Confirmed diagnosis of multiple myeloma, lymphoma, breast cancer, ovarian cancer, small-cell lung cancer, esophagus cancer, or prostate cancer
- receiving treatment with chemotherapy, with at least 3 additional months of chemotherapy planned
- a self-care performance score of 0 (fully active, no disease restriction) to 3 (capable of only limited self-care, confined to bed or chair more than 50% of waking hours)
- life expectancy of at least 6 months
- baseline hemoglobin \<12 grams per deciliter and baseline count of \<100,000 microliter for developing red cells
Exclusion
- Clinically significant disease other than cancer
- evidence of uncontrolled hypertension or history of seizure
- transfusion within 1 week of the study
- radiotherapy within 2 weeks of study start
- use of corticosteroid or steroid drugs during the study.
Key Trial Info
Start Date :
February 1 1995
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 1998
Estimated Enrollment :
201 Patients enrolled
Trial Details
Trial ID
NCT00270166
Start Date
February 1 1995
End Date
May 1 1998
Last Update
May 18 2011
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