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

This study is currently recruiting participants. (see Contacts and Locations)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 September 22, 2014