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

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

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.

Study Overview

• Status: Completed
• Conditions: Antineoplastic Chemotherapy Induced Anemia
• Intervention / Treatment: Biological: Epoetin alfa

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 Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 4

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina
    • Centro de Medicina Integral e Investigación Clínica
  • Buenos Aires
    • Berazategui, Buenos Aires, Argentina
      • Centro Oncologico de Investigaciones Buenos Aires
    • Lanus Este, Buenos Aires, Argentina, CP 1824
      • Hospital Zonal Especializado en Oncología de Lanus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: Open Label; One arm open label	Biological: Epoetin alfa; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Bio Sidus SA
• Collaborators: IC RESEARCH GROUP
• Investigators: Study Director: Roberto Diez, MD, Bio Sidus SA

Study record dates

Study Major Dates

• Study Start: June 1, 2011
• Primary Completion (ACTUAL): November 1, 2014
• Study Completion (ACTUAL): November 1, 2014

Study Registration Dates

• First Submitted: June 13, 2011
• First Submitted That Met QC Criteria: June 15, 2011
• First Posted (ESTIMATE): June 16, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): April 7, 2016
• Last Update Submitted That Met QC Criteria: April 6, 2016
• Last Verified: April 1, 2016

More Information

Terms related to this study

• Keywords: Anemia; Chemotherapy; Epoetin alfa; Erythropoiesis stimulating agent (ESA)
• Additional Relevant MeSH Terms: Hematologic Diseases; Anemia; Hematinics; Epoetin Alfa
• Other Study ID Numbers: BIOS-012010