Treatment for Patients With Non-Myeloid Malignancies Receiving Chemotherapy

Study Overview
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Brief Summary
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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.

Official Title
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A Randomized, Open Label Study to Assess Time to Hemoglobin Response of a Front Load Dosing Regimen for Darbepoetin Alfa Compared to a Weekly Dose Regimen for Recombinant Human Erythropoietin in Patients With Non-Myeloid Malignancies Receiving Chemotherapy

Conditions
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Cancer, Non-Myeloid Malignancies

Intervention / Treatment
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* Drug: rHuEPO
* Drug: Darbepoetin alfa


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: rHuEPO<br> | Drug: rHuEPO<br>* rHuEPO 40,000U QW for 4 weeks. Dose will be increased to 60,000U/week at week 5 if inadequate response through week 12.<br>|
| Experimental: Darbepoetin alfa<br> | Drug: Darbepoetin alfa<br>* 4.5 mcg/kg QW for 4 weeks then Q3W starting at week 5 through week 11.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to hematopoietic response during the comparative treatment period |  | during the comparative treatment period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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darbepoetin alfa, anemia, Amgen, Chemotherapy