Hematologic Response of Epoetin Alfa (PROCRIT) Versus Darbepoetin Alfa (ARANESP) in Chemotherapy Induced Anemia

• Status: Completed
• Trial end date: 2004-10-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to compare hemoglobin (Hgb) response rates between epoetin alfa (PROCRIT; 40,000 Units (U) SC weekly) and darbepoetin alfa (ARANESP; 200 mcg every other week) in anemic cancer patients receiving chemotherapy.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ortho Biotech Products, L.P.
• Treatments: Darbepoetin alfa; Epoetin Alfa

Criteria

Inclusion Criteria:

• Histologically confirmed diagnosis of a solid tumor malignancy

• Baseline hemoglobin value of <11 g/dL

• Scheduled to receive cyclic chemotherapy for a minimum of 12 weeks

• < 2 prior chemotherapy regimens in a metastatic setting

• Adequate hematologic & renal function and platelet count >100,000/mm3

• Estimated life expectancy of > 6 months

• Eastern Cooperative Oncology Group (ECOG) Performance Status 0 - 2

Exclusion Criteria:

• History of stem cell or bone marrow transplant

• Anemia due to factors other than cancer/chemotherapy

• Prior treatment with epoetin alfa or darbepoetin alfa or any investigational forms of erythropoietin within the previous 3 months

• Significant, uncontrolled disease/dysfunction of the pulmonary, cardiovascular, endocrine, neurologic, gastrointestinal, or genitourinary systems not attributable to underlying malignancy or chemotherapy

• Uncontrolled hypertension or recent history (within 6 months) of uncontrolled cardiac arrhythmias, pulmonary embolism, thrombosis

• new onset of seizures

• history of second active malignancy

• Major infection requiring hospitalization and antibiotics within 14 days of randomization

• Transfusion of white blood cells or packed red blood cells within 28 days of randomization.