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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01374373
First Posted: June 16, 2011
Last Update Posted: April 7, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
IC RESEARCH GROUP
Information provided by (Responsible Party):
Bio Sidus SA
  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: Intervention Model: Single Group Assignment
Masking: None (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 ]

Secondary Outcome Measures:
  • Hemoglobin levels and percentage of responders [ Time Frame: Every 4 weeks and 12 weeks ]
    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 ]
    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 ]
    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


Enrollment: 30
Study Start Date: June 2011
Study Completion Date: November 2014
Primary Completion Date: November 2014 (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

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

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01374373


Locations
Argentina
Centro Oncologico de Investigaciones Buenos Aires
Berazategui, Buenos Aires, Argentina
Hospital Zonal Especializado en Oncología de Lanus
Lanus Este, Buenos Aires, Argentina, CP 1824
Centro de Medicina Integral e Investigación Clínica
Buenos Aires, Argentina
Sponsors and Collaborators
Bio Sidus SA
IC RESEARCH GROUP
Investigators
Study Director: Roberto Diez, MD Bio Sidus SA
  More Information

Responsible Party: Bio Sidus SA
ClinicalTrials.gov Identifier: NCT01374373     History of Changes
Other Study ID Numbers: BIOS-012010
First Submitted: June 13, 2011
First Posted: June 16, 2011
Last Update Posted: April 7, 2016
Last Verified: April 2016

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

Additional relevant MeSH terms:
Anemia
Hematologic Diseases
Epoetin Alfa
Hematinics