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

Bio Sidus SA30 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Antineoplastic Chemotherapy Induced Anemia

Interventions

Epoetin alfaBIOLOGICAL

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (3)

Centro Oncologico de Investigaciones Buenos Aires

Berazategui, Buenos Aires, Argentina

Centro de Medicina Integral e Investigación Clínica

Buenos Aires, Buenos Aires, Argentina

Hospital Zonal Especializado en Oncología de Lanus

Lanús Este, Buenos Aires, Argentina

Outcomes

Primary Outcomes

Number of subjects with adverse events and percentage of therapy withdrawals due to treatment emergent adverse events

Time frame: Baseline to 12 weeks

Secondary Outcomes

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

Time frame: 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

Time frame: 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

Time frame: 12 weeks

Data from ClinicalTrials.gov

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