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

NCT ID: NCT01374373

Last Updated: 2016-04-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-06-30
• Study Completion Date: 2014-11-30

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.

Conditions

Antineoplastic Chemotherapy Induced Anemia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Open Label

One arm open label

Group Type: OTHER

Epoetin alfa

Intervention Type: BIOLOGICAL

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

Interventions

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

Intervention Type: BIOLOGICAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

IC RESEARCH GROUP

UNKNOWN

Sponsor Role: collaborator

Bio Sidus SA

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Roberto Diez, MD

Role: STUDY_DIRECTOR

Bio Sidus SA

Locations

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

Countries

Argentina

Other Identifiers

BIOS-012010

Identifier Type: -

Identifier Source: org_study_id