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

This study is currently recruiting participants.
Verified December 2012 by Bio Sidus SA
Sponsor:
Collaborator:
IC RESEARCH GROUP
Information provided by (Responsible Party):
Bio Sidus SA
ClinicalTrials.gov Identifier:
NCT01374373
First received: June 13, 2011
Last updated: December 13, 2012
Last verified: December 2012
  Purpose

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.


Condition Intervention Phase
Antineoplastic Chemotherapy Induced Anemia
Biological: Epoetin alfa
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 4 Study in the Treatment of Anemia With Weekly Epoetin Alfa Doses in Patients With Solid Tumors or Lymphoma Receiving Chemotherapy

Resource links provided by NLM:


Further study details as provided by Bio Sidus SA:

Primary Outcome Measures:
  • Number of subjects with adverse events and percentage of therapy withdrawals due to treatment emergent adverse events [ Time Frame: Baseline to 12 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Hemoglobin levels and percentage of responders [ Time Frame: Every 4 weeks and 12 weeks ] [ Designated as safety issue: No ]
    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

  • Quality of life [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
    Evaluate if treatment impacts quality of life assessed through the Brief Fatigue Index (BFI) score comparing baseline with final 12 week visit

  • Hemoglobin levels ≥ 2 g/dl [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 30
Study Start Date: June 2011
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Other Name: 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01374373

Contacts
Contact: Roberto Diez, MD 5411-4909-8049 r.diez@biosidus.com.ar

Locations
Argentina
Centro Oncologico de Investigaciones Buenos Aires Recruiting
Berazategui, Buenos Aires, Argentina
Contact: Mirta Varela, MD         
Hospital Zonal Especializado en Oncología de Lanus Recruiting
Lanus Este, Buenos Aires, Argentina, CP 1824
Contact: Eduardo Diez, MD    5411-4241-2968    terapeutica.lanus@yahoo.com.ar   
Centro de Medicina Integral e Investigación Clínica Recruiting
Buenos Aires, Argentina
Contact: Carlos Guzman Machado, MD         
Sponsors and Collaborators
Bio Sidus SA
IC RESEARCH GROUP
Investigators
Study Director: Roberto Diez, MD Bio Sidus SA
  More Information

No publications provided

Responsible Party: Bio Sidus SA
ClinicalTrials.gov Identifier: NCT01374373     History of Changes
Other Study ID Numbers: BIOS-012010
Study First Received: June 13, 2011
Last Updated: December 13, 2012
Health Authority: Argentina: Ministry of Health

Keywords provided by Bio Sidus SA:
Chemotherapy
Anemia
Epoetin alfa
Erythropoiesis stimulating agent (ESA)

Additional relevant MeSH terms:
Anemia
Hematologic Diseases
Epoetin Alfa
Hematinics
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014