A Study to Evaluate the Hematologic Response Rate (the Rate at Which the Hemoglobin Level Rises) of PROCRIT (Epoetin Alfa) Given at a Dose of 80,000 Units Once Weekly to Cancer Patients With Anemia Who Are Receiving Chemotherapy.

• Status: Completed
• Trial end date: 2004-05-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the hematologic response, safety, and clinical outcomes of PROCRIT administered once a week in anemic cancer patients receiving chemotherapy.

• 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:

• Patients with a confirmed diagnosis of any non-myeloid malignancy planned to have received at least 12 weeks of chemotherapy with hemoglobin <= 11 g/dL

• Life expectancy > 6 months with Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2

• Both male and female patients with reproductive potential must have used an adequate contraceptive method (e.g., abstinence, intrauterine device, oral contraceptives, barrier device with spermicide or surgical sterilization) during treatment and for three months after completing treatment. Female patients with reproductive potential had a negative serum pregnancy test within 7 days of the first dose of study drug.

Exclusion Criteria:

• Previous radiation therapy to > 25% bone marrow reserve or planned radiation during study duration

• Packed red blood cells (PRBC) transfusion within 28 days of study entry

• Anemia due to factors other than cancer/chemotherapy, i.e., iron, folate, Vitamin B12 deficiency, hemolysis or GI bleeding

• Previous treatment with Epoetin alfa or any investigational forms of erythropoietin (e.g., gene-activated erythropoietin, novel erythropoiesis stimulating protein) within the previous 3 months

• uncontrolled hypertension or history of thrombotic vascular events