An Efficacy and Safety Study for Epoetin Alfa (PROCRIT) in Cancer Patients Not Receiving Chemotherapy or Radiation

• Status: Completed
• Trial end date: 2005-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the effectiveness and safety of epoetin alfa (PROCRIT®) administered 80,000 Units every three weeks in cancer patients that are not receiving chemotherapy or radiation therapy.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
• Collaborator: Ortho Biotech Products, L.P.
• Treatments: Epoetin Alfa

Criteria

Inclusion Criteria:

• Histologically confirmed diagnosis of non-myeloid malignancy

• Baseline hemoglobin value of <= 11 g/dL unrelated to transfusion

• Patients must not be receiving or planning to receive chemotherapy or radiotherapy within the 13-week study period. However, patients receiving hormonal therapy or non-myelosuppressive therapies are allowable

• Female patients with reproductive potential must have a negative serum pregnancy test at screening

• Patients must have signed an informed consent

Exclusion Criteria:

• Uncontrolled hypertension

• History (within 6 months) 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

• Transfusion within 28 days prior to first dose

• Planned chemotherapy or radiation during study and no prior chemotherapy within 8 weeks or radiation within 4 weeks of study entry

• No prior treatment with Epoetin alfa or any other erythropoietic agent within the previous two months