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Completed

NCT Number: NCT01374373

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

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.

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Key information

Conditions

Antineoplastic Chemotherapy Induced Anemia Anemia Hematologic Diseases Hemic and Lymphatic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Centro Oncologico de Investigaciones Buenos Aires, Berazategui, Buenos Aires, Argentina

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

epoetin alfa

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

Primary outcomes

  1. Number of subjects with adverse events and percentage of therapy withdrawals due to treatment emergent adverse events

    Time frame: Baseline to 12 weeks

Secondary outcomes

  1. 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

  2. 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

  3. 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

Sponsors and collaborators

Lead sponsor

Bio Sidus SA

Industry

Collaborators

  • IC RESEARCH GROUP

Registry information

Official study title

A Phase 4 Study in the Treatment of Anemia With Weekly Epoetin Alfa Doses in Patients With Solid Tumors or Lymphoma Receiving Chemotherapy

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Jun 16, 2011
Registry last updated
Apr 7, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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