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

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Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IVSupportive careActive18 and overPharmaceutical / IndustryBIOS-012010
NCT01374373

Trial Description

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.

Further Study Information

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.

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

Trial Contact Information

Trial Lead Organizations/Sponsors

Bio Sidus SA

  • IC RESEARCH GROUP
Roberto Diez, MD, Study Director
Roberto Diez, MD
Ph: 5411-4909-8049
Email: r.diez@biosidus.com.ar

Trial Sites

Argentina

Buenos Aires

Centro de Medicina Integral e Investigación Clínica

Carlos Guzman Machado, MD

Buenos Aires
Berazategui

Centro Oncologico de Investigaciones Buenos Aires

Mirta Varela, MD

Lanus Este

Hospital Zonal Especializado en Oncologia de Lanus

Eduardo Diez, MD
Ph: 5411-4241-2968
Email: terapeutica.lanus@yahoo.com.ar

Link to the current ClinicalTrials.gov record.
NLM Identifier NCT01374373
ClinicalTrials.gov processed this data on April 09, 2015

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.