Status:
COMPLETED
Early and Standard Intervention With 120,000 Units of PROCRIT (Epoetin Alfa) Every Three Weeks in Patients 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 purpose of this study is to evaluate the safety and efficacy of PROCRIT (Epoetin alfa) when administered at 120,000 Units once every three weeks by comparing early dosing (Hb 11g/dL-12g/dL) vs. st...
Detailed Description
This is a randomized, open-label, multi-center study. Eligible patients will be identified during the screening phase. After randomization, the Treatment Phase will start at the Day 1, Week 1 visit. T...
Eligibility Criteria
Inclusion
- Biopsy confirmed diagnosis of non-myeloid malignancy
- Baseline hemoglobin (Hb) value of \>= 11.0 g/dL and \<= 12.0 g/dL
- No blood transfusions in the 28 days prior to the start of Treatment Phase
- Must be receiving chemotherapy or will begin receiving chemotherapy at start of Treatment
- Iron transferrin saturation (TSAT) \> 20% or if TSAT\<20%, serum ferritin must be greater than 100 ng/mL.
Exclusion
- No myeloid malignancy or known history of myelodysplasia
- No planned radiation during the study
- Prior treatment with Epoetin alfa or any other erythropoietic agent (e.g., Darbepoetin alfa, gene-activated erythropoietin) within the previous three months
- No uncontrolled disease/dysfunction of the lung, cardiovascular, endocrine, neurologic, gastrointestinal, or genitourinary systems
- No history of uncontrolled cardiac arrhythmias (within 6 months) or pulmonary emboli, deep vein thrombosis, ischemic stroke, other arterial or venous thrombotic events (excluding superficial thromboses), or known history of chronic hypercoagulable disorders
- Has not received an experimental drug or device within the past 30 days
Key Trial Info
Start Date :
May 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2006
Estimated Enrollment :
186 Patients enrolled
Trial Details
Trial ID
NCT00210600
Start Date
May 1 2005
End Date
August 1 2006
Last Update
June 10 2011
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