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

Study Overview
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Brief Summary
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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

Detailed Description
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This is an open-label (both the physician and the patient know which treatment is being provided), multi-center study of up to 16 weeks duration in which 450 patients will be randomly assigned (patients are assigned to a specific study group by chance) to one of three treatment groups in a 1:1:1 ratio. Patients will receive PROCRIT (epoetin alfa) 80,000 Units injected subcutaneously (under the skin) once every three weeks or 120,000 Units injected under the skin once every three weeks or ARANESP (darbepoetin alfa) 500 mcg injected under the skin once every three weeks for up to 13 weeks. PROCRIT (epoetin alfa) 80,000 Units and 120,000 Units given once every three weeks are doses and schedules that are not approved for use in the United States and are under investigation, while the ARANESP dose and schedule are approved for use in the United States. Adult patients with specific types of cancer (confirmed non-myeloid malignancy) who are scheduled to receive cyclic chemotherapy for a minimum of 12 weeks during the study and who meet all other eligibility criteria will be enrolled. This study will be conducted in approximately 80 study sites located in the United States. The study hypothesis is that a dosing regimen of PROCRIT (Epoetin alfa) 80,000 Units or 120,000 Units given once every three weeks is non-inferior to ARANESP 500 mcg given once every three weeks with respect to the mean hemoglobin (Hb) change from baseline to Study Week 7 in anemic cancer patients receiving chemotherapy. Hemoglobin levels will be monitored throughout the study on a weekly basis and before each drug dose is administered. Drug dosing will be adjusted (ie, held, reduced, resumed at a lower dose) as needed to maintain hemoglobin values within desired ranges. The maximum dose of PROCRIT (Epoetin alfa) allowed in this study is 120,000 Units every three weeks (Q3W) and the maximum dose of ARANESP (darbepoetin) is 500 mcg Q3W. Safety evaluations will be conducted throughout the study and will consist of assessment of laboratory tests, vital signs, physical examinations. The occurrence and severity of adverse events, including thrombovascular events will be evaluated throughout the study.Periodic data monitoring of the study by an external Independent Data Monitoring Committee (IDMC) will be performed. The main responsibility of the IDMC is to conduct ongoing monitoring of safety and to report any irregularities back to the Sponsor along with recommendations regarding continuation of the study. Each patient will be assigned to one of three dosing schedules. All schedules will be administered by way of subcutaneous (under the skin) injection once every three weeks over a period of 13 weeks. The three dosing schedules are as follows: PROCRIT (epoetin alfa) 80,000 Units, PROCRIT (epoetin alfa) 120,000 Units or ARANESP (darbepoetin alfa) 500 mcg

Official Title
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A Randomized, Open-Label, Comparative Study of Epoetin Alfa (PROCRIT) 80,000 Units or 120,000 Units Q3W (Every 3 Weeks) Versus Darbepoetin Alfa (ARANESP) 500 Mcg Q3W in Anemic Cancer Subjects Receiving Chemotherapy

Conditions
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Neoplasms, Anemia, Cancer

Intervention / Treatment
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* Drug: epoetin alfa
* Drug: darbepoetin alfa


Participation Criteria
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Eligibility Criteria
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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

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 |
| --- | --- |
| Experimental: epoetin alfa (120,000 Units)<br>epoetin alfa (PROCRIT) 120,000 Units injected subcutaneously once every 3 weeks for up to 13 weeks | Drug: epoetin alfa<br>* 80,000 Units and 120,000 Units of epoetin alfa (PROCRIT) injected subcutaneously once every 3 weeks for up to 13 weeks<br>* Other names: PROCRIT;|
| Experimental: epoetin alfa (80,000 Units)<br>epoetin alfa (PROCRIT) 80,000 Units injected subcutaneously once every 3 weeks for up to 13 weeks | Drug: epoetin alfa<br>* 80,000 Units and 120,000 Units of epoetin alfa (PROCRIT) injected subcutaneously once every 3 weeks for up to 13 weeks<br>* Other names: PROCRIT;|
| Active Comparator: darbepoetin alfa (500 mcg)<br>darbepoetin alfa (ARANESP) 500 mcg injected subcutaneously the skin once every 3 weeks for up to 13 weeks | Drug: darbepoetin alfa<br>* 500 mcg of darbepoetin alfa (ARANESP) injected subcutaneously the skin once every 3 weeks for up to 13 weeks<br>* Other names: ARANESP;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemoglobin (Hb) Change From Baseline to Study Week 7 | Baseline Hb was the Hb value that was consistent with the inclusion criteria and which was obtained within 72 hours of the first dose of study medication | Baseline (Week 1) and Week 7 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Patients Receiving at Least 1 Packed Red Blood Cell (PRBC) Transfusion During Study |  | up to 16 weeks | 
| Time to Achieve Hb >= 11 g/dL During Study |  | up to 16 weeks | 
| Number of Patients (Hb >= 11 g/dL) During Study. |  | up to 16 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anemia, Cancer, Chemotherapy-Induced Anemia, Epoetin alfa, Darbepoetin alfa