Treatment for Patients With Non-Myeloid Malignancies Receiving Chemotherapy

• Status: Completed
• Trial end date: 2004-04-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to compare the time to hematopoietic response (hemoglobin correction to 12 g/dL or a greater than or equal to 2 g/dL increase from baseline) for subjects randomized to receive darbepoetin alfa with a front load dosing regimen to those receiving recombinant human erythropoietin (rHuEPO) with a weekly dose regimen during the 12-week comparative treatment period.

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

Details

• Lead Sponsor: Amgen
• Treatments: Darbepoetin alfa; Epoetin Alfa

Criteria

Inclusion Criteria:

• Subjects with non-myeloid malignancies planning to receive cyclic chemotherapy for 8 additional weeks or more

• Anemia (hemoglobin [hgb] greater than or equal to 9.0g/dL and less than or equal to 11.0 g/dL) related to cancer and chemotherapy

• Karnofsky performance status of greater than or equal to 50%

• Serum bilirubin less than or equal to 2.5 times the upper limit of normal range and serum creatinine concentration of less than or equal to 2.0 mg/dL

Exclusion Criteria:

• Acute myelogenous leukemia (AML), chronic myelogenous leukemia (CML), or myelodysplastic syndromes

• Hematologic disorder previously associated with anemia

• Active bleeding

• Iron deficiency

• Received erythropoietic therapy within 14 days prior to randomization

• Unstable cardiac disease

• Known positive human immunodeficiency virus antibody or hepatitis B surface antigen

• Known positive antibody response to any erythropoietic agent

• Currently enrolled in, or has not yet completed at least 30 days since ending other investigational device or drug trial or is receiving investigational agent(s) not approved for any indication

• Pregnant or breast feeding

• Red blood cell (RBC) transfusion within 4 weeks of screening

• Known hypersensitivity to any recombinant mammalian-derived product