A Study Comparing Two Different PROCRIT Doses to a Dose of ARANESP in Anemic Cancer Patients Receiving Chemotherapy

• Status: Terminated
• Trial end date: 2008-05-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to compare hemoglobin response rates between two PROCRIT (epoetin alfa) doses and ARANESP (darbepoetin alfa) in anemic cancer patients receiving chemotherapy

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
• Collaborator: Ortho Biotech Clinical Affairs, L.L.C.
• Treatments: Darbepoetin alfa; Epoetin Alfa

Criteria

Inclusion Criteria:

• Histologically confirmed diagnosis of a non-myeloid malignancy

• Baseline hemoglobin (Hb) value of <= 11.0 g/dL unrelated to transfusion

• No Packed Red Blood Cell (PRBC) or platelet transfusions in the 28 days prior to randomization

• Scheduled to receive chemotherapy for a minimum of 12 weeks during the study

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

Exclusion Criteria:

• No planned non-palliative radiation during the study

• No current anemia due to factors other than cancer/chemotherapy (eg, iron deficiency or gastrointestinal bleeding)

• No uncontrolled hypertension (defined as systolic pressure > 180 and/or a diastolic pressure > 100 mmHg while receiving antihypertension therapy)

• No history of Deep Venous Thrombosis (DVT) or Pulmonary Embolus (PE) within 12 months before study enrollment. Prior superficial thrombophlebitis is not an exclusion criterion

• No history of Cerebrovascular Accident (CVA), Transient Ischemic Attack (TIA), Acute Coronary Syndrome (ACS) including unstable angina and myocardial infarction with or without ST elevation, or other arterial thrombosis within 6 months before study enrollment