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

Phase 4

Completed

• Conditions: Antineoplastic Chemotherapy Induced Anemia
• Interventions: Biological: Epoetin alfa

• Registration Number: NCT01374373
• Lead Sponsor: Bio Sidus SA

Brief Summary

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

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 Timeline

• Study Start: 2011-06
• Study First Submitted: 2011-06-13
• Study First Submitted QC: 2011-06-15
• Study First Posted: 2011-06-16
• Primary Completion: 2014-11
• Study Completion: 2014-11
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-06
• Last Update Posted: 2016-04-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Open Label	Epoetin alfa	One arm open label

Primary Outcome Measures

Name	Time	Method
Number of subjects with adverse events and percentage of therapy withdrawals due to treatment emergent adverse events	Baseline to 12 weeks

Secondary Outcome Measures

Name	Time	Method
Quality of life	12 Weeks	Evaluate if treatment impacts quality of life assessed through the Brief Fatigue Index (BFI) score comparing baseline with final 12 week visit
Hemoglobin levels and percentage of responders	Every 4 weeks and 12 weeks	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
Hemoglobin levels ≥ 2 g/dl	12 weeks	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

Trial Locations

Locations (3)

Hospital Zonal Especializado en Oncología de Lanus; 🇦🇷 Lanus Este, Buenos Aires, Argentina

Centro Oncologico de Investigaciones Buenos Aires; 🇦🇷 Berazategui, Buenos Aires, Argentina

Centro de Medicina Integral e Investigación Clínica; 🇦🇷 Buenos Aires, Argentina