Status:
COMPLETED
An Efficacy and Safety Study of PROCRIT (Epoetin Alfa) in Cancer Patients Receiving Chemotherapy Every Three Weeks
Lead Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Collaborating Sponsors:
Ortho Biotech Products, L.P.
Conditions:
Cancer
Anemia
Eligibility:
All Genders
19+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to determine the effectiveness and safety of PROCRIT (Epoetin alfa) at a starting dose of 60,000 Units (U) once every week (QW) to a target hemoglobin (Hb) of 12 g/dL (Ini...
Detailed Description
Epoetin alfa administered three times weekly (150 U/kg) or once weekly (40,000 U) results in a response rate (defined as \>= 2 g/dL Hb increase or Hb \>= 12 g/dL) of approximately 65% of anemic chemot...
Eligibility Criteria
Inclusion
- Histologically confirmed diagnosis of non-myeloid malignancy and receiving chemotherapy
- Baseline Hb of \<= 11 g/dL
- Planned chemotherapy for a minimum of 15 weeks to be administered every 3 weeks
- Female patients with reproductive potential must have a negative serum pregnancy test at screening.
Exclusion
- No uncontrolled hypertension or recent history (within 6 months) of uncontrolled cardiac arrhythmias
- No pulmonary embolism
- or thrombosis
- No transfusion of white blood cells or packed red blood cells within 28 days of Epoetin alfa treatment
- No prior treatment with Epoetin alfa or any other erythropoetic agent within the previous three months
Key Trial Info
Start Date :
March 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2005
Estimated Enrollment :
115 Patients enrolled
Trial Details
Trial ID
NCT00338416
Start Date
March 1 2003
End Date
January 1 2005
Last Update
June 10 2011
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