Status:
COMPLETED
Epoetin Alfa for Anemia in Patients With Cancer Receiving Non-platinum Chemotherapy
Lead Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Conditions:
Anemia
Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to evaluate the effectiveness of epoetin alfa versus placebo in reducing or preventing the need for transfusions in anemic patients with non-myeloid cancer on non-platinum...
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 fatigue associated with anemia. Previous studies with epo...
Eligibility Criteria
Inclusion
- Confirmed diagnosis of non-myeloid malignancy
- undergoing treatment with non-platinum-containing chemotherapy, or non-platinum-containing chemotherapy is imminent
- Eastern Cooperative Oncology Group (which is a scale used by researchers to represent the level of activity that a patient is capable of) 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 \<= 10.5 grams per deciliter (or a fall in hemoglobin level \>= 1.5 grams per deciliter per cycle or per month since the beginning of the current course of chemotherapy such that it dropped to \<= 12 grams per deciliter) and baseline count of \<125,000 microliters for developing red cells
Exclusion
- Patients having a clinically significant disease other than cancer
- treated by platinum-containing chemotherapy within 3 months of study start
- having uncontrolled high blood pressure, a history of seizure, or untreated iron, folate, or Vitamin B12 deficiency
- received a transfusion or radiotherapy within 2 weeks of study start, or had surgery within 1 week of study start
- intending to use steroid drugs during the study
Key Trial Info
Start Date :
August 1 1996
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 1998
Estimated Enrollment :
375 Patients enrolled
Trial Details
Trial ID
NCT00270127
Start Date
August 1 1996
End Date
September 1 1998
Last Update
May 18 2011
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