Status:
COMPLETED
An Efficacy and Safety Study of Epoetin Alfa (PROCRIT) Initiated at 40,000 Units Every Week Versus 80,000 Units Every Two Weeks in Anemic Patients With Cancer Receiving Chemotherapy.
Lead Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Collaborating Sponsors:
Ortho Biotech Products, L.P.
Conditions:
Anemia
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The primary objective of this study is to compare end of study hemoglobin levels between Epoetin alfa at 40,000 units administered subcutaneously once every week and at 80,000 units subcutaneously eve...
Detailed Description
This is a randomized, open-label, multi-center study to compare end of study hemoglobin level between Epoetin alfa (PROCRIT) at 40,000 units administered subcutaneously once every week (qw) and at 80,...
Eligibility Criteria
Inclusion
- Histologically confirmed diagnosis of non-myeloid malignancy
- Baseline hemoglobin value of \<= 11 g/dL unrelated to transfusion
- Planned chemotherapy for a minimum of 12 weeks during the study
- Life expectancy of \>= 6 months
- ECOG Performance Status 0-2
Exclusion
- Diagnosis of a myeloid malignancy or known history of myelodysplasia
- Planned non-palliative radiation during the study
- Anemia due to factors other than cancer/chemotherapy
- Prior treatment with Epoetin alfa or any other erythropoietic agent within the previous three months
- History of uncontrolled cardiac arrhythmias or history of pulmonary emboli, deep vein thrombosis, ischemic stroke, other arterial or venous thrombotic events (excluding superficial thromboses), or known history of chronic coagulation disorder
Key Trial Info
Start Date :
May 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2005
Estimated Enrollment :
310 Patients enrolled
Trial Details
Trial ID
NCT00210834
Start Date
May 1 2004
End Date
September 1 2005
Last Update
June 10 2011
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