Epoetin Alfa (Hemax®) Phase IV Study in Chemotherapy Induced Anemia

Study Overview
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Brief Summary
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The purpose of this study is to assess safety and efficacy of weekly epoetin alfa (Hemax® ) administered for 12 weeks in patients with non curable solid tumors or lymphoma with anemia (hemoglobin < 10g/dl) undergoing palliative care chemotherapy.

Detailed Description
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Patients with non curable solid tumors or lymphoma with anemia (hemoglobin < 10g/dl) undergoing palliative care chemotherapy will enter this 12 week single arm open label study. Epoetin alfa 40.000-60.000 IU/week will be administered subcutaneously and controlled every 2 weeks. Up or down titration will be performed according to the currently approved prescription guidance for a total of 12 weeks of treatment. Study end points will be assessed every 4 weeks until final 12 week visit.

Official Title
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A Phase 4 Study in the Treatment of Anemia With Weekly Epoetin Alfa Doses in Patients With Solid Tumors or Lymphoma Receiving Chemotherapy

Conditions
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Antineoplastic Chemotherapy Induced Anemia

Intervention / Treatment
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* Biological: Epoetin alfa


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Confirmed diagnosis of non curable cancer or lymphoma Receiving a palliative chemotherapy regimen Hemoglobin < 10.0 g/dL Performance ≤ 3 of Eastern Cooperative Oncology Group (ECOG) performance status Life expectancy of ≥ 3 months Postmenopausal o premenopausal women receiving effective contraceptive method Exclusion Criteria: Active bleeding that may have caused anemia in the prior 30 days. Uncontrolled hypertension Anemia for another cause other than cancer or chemotherapy Untreated iron or folic acid deficiency Transfusion in the last 30 days prior to baseline visit Treatment with an erythropoiesis stimulating agent 3 months prior to the baseline visit Increased risk of thromboembolic disease Radiotherapy in pelvis or spine in the last 60 days Myelodysplasic syndrome History of congestive heart failure Pregnant or lactating Patient with known allergy to human albumin or related products

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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Open Label<br>One arm open label | Biological: Epoetin alfa<br>* Epoetin alfa 40.000-60.000 IU/week subcutaneously that will be controlled and up or down titrated every 2 weeks according to the currently approved prescription guidance for a total of 12 weeks of treatment with Co administration of oral ferrous sulfate 200mg BID and oral folic acid 5mg QD<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of subjects with adverse events and percentage of therapy withdrawals due to treatment emergent adverse events |  | Baseline to 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemoglobin levels and percentage of responders | Evaluate efficacy assessing hemoglobin levels and percentage of responders (increments of Hemoglobin ≥ 1g/dl without transfusion requirements) comparing baseline with final 12 week and intermediate 4 week visits | Every 4 weeks and 12 weeks | 
| Quality of life | Evaluate if treatment impacts quality of life assessed through the Brief Fatigue Index (BFI) score comparing baseline with final 12 week visit | 12 Weeks | 
| Hemoglobin levels ≥ 2 g/dl | Evaluate proportion of patient that achieve hemoglobin levels ≥ 2 g/dl without transfusion requirements and the number of patients that require at least one transfusion after 12 weeks of therapy | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chemotherapy, Anemia, Epoetin alfa, Erythropoiesis stimulating agent (ESA)