Treatment for Patients With Non-Myeloid Malignancies Receiving Chemotherapy

Phase 3

Completed

• Conditions: Cancer; Non-Myeloid Malignancies
• Interventions: Drug: Darbepoetin alfa; Drug: rHuEPO

• Registration Number: NCT00111137
• Lead Sponsor: Amgen

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-02
• Primary Completion: 2003-11
• Study Completion: 2004-04
• Study First Submitted: 2005-05-17
• Study First Submitted QC: 2005-05-17
• Study First Posted: 2005-05-18
• Status Verified: 2008-02
• Last Update Submitted: 2008-02-20
• Last Update Posted: 2008-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 718

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Darbepoetin alfa	Darbepoetin alfa	-
rHuEPO	rHuEPO	-

Primary Outcome Measures

Name	Time	Method
Time to hematopoietic response during the comparative treatment period	during the comparative treatment period

Secondary Outcome Measures

Name	Time	Method
Exploratory analyses for other patient reported outcome scales collected during the study (FACT-Anemia, BSI, EQ-5D, and Patient Satisfaction Questionnaire for Injectable Anemia Treatment)	during the study
Incidence, if any, of neutralizing antibody formation to study drug	throughout study
Difference between the average hemoglobin after the first month of treatment compared to the baseline hemoglobin	baseline to first month of treatment
Time to 2 g/dL increase in hemoglobin during the comparative treatment period	during the comparative treatment period
Change in FACT-Fatigue scale score over time during the comparative treatment period	during the comparative treatment period
Overall incidence of adverse events, serious adverse events and related adverse events as measured throughout study	throughout study
Slope of change in hemoglobin after the first month of treatment	baseline to first month of treatment
Red blood cell usage during the treatment period and other changes in hemoglobin during the comparative treatment period	during the comparative treatment period
Changes in hemoglobin during the maintenance period	during the maintenance period