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

Primary Purpose

Antineoplastic Chemotherapy Induced Anemia

Status
Completed
Phase
Phase 4
Locations
Argentina
Study Type
Interventional
Intervention
Epoetin alfa
Sponsored by
Bio Sidus SA
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Antineoplastic Chemotherapy Induced Anemia focused on measuring Chemotherapy, Anemia, Epoetin alfa, Erythropoiesis stimulating agent (ESA)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Centro Oncologico de Investigaciones Buenos Aires
  • Hospital Zonal Especializado en Oncología de Lanus
  • Centro de Medicina Integral e Investigación Clínica

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Open Label

Arm Description

One arm open label

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Hemoglobin levels and percentage of responders
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
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
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

Full Information

First Posted
June 13, 2011
Last Updated
April 6, 2016
Sponsor
Bio Sidus SA
Collaborators
IC RESEARCH GROUP
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1. Study Identification

Unique Protocol Identification Number
NCT01374373
Brief Title
Epoetin Alfa (Hemax®) Phase IV Study in Chemotherapy Induced Anemia
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
June 2011 (undefined)
Primary Completion Date
November 2014 (Actual)
Study Completion Date
November 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bio Sidus SA
Collaborators
IC RESEARCH GROUP

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Antineoplastic Chemotherapy Induced Anemia
Keywords
Chemotherapy, Anemia, Epoetin alfa, Erythropoiesis stimulating agent (ESA)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Open Label
Arm Type
Other
Arm Description
One arm open label
Intervention Type
Biological
Intervention Name(s)
Epoetin alfa
Intervention Description
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 Outcome Measure Information:
Title
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 Measure Information:
Title
Hemoglobin levels and percentage of responders
Description
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
Time Frame
Every 4 weeks and 12 weeks
Title
Quality of life
Description
Evaluate if treatment impacts quality of life assessed through the Brief Fatigue Index (BFI) score comparing baseline with final 12 week visit
Time Frame
12 Weeks
Title
Hemoglobin levels ≥ 2 g/dl
Description
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
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roberto Diez, MD
Organizational Affiliation
Bio Sidus SA
Official's Role
Study Director
Facility Information:
Facility Name
Centro Oncologico de Investigaciones Buenos Aires
City
Berazategui
State/Province
Buenos Aires
Country
Argentina
Facility Name
Hospital Zonal Especializado en Oncología de Lanus
City
Lanus Este
State/Province
Buenos Aires
ZIP/Postal Code
CP 1824
Country
Argentina
Facility Name
Centro de Medicina Integral e Investigación Clínica
City
Buenos Aires
Country
Argentina

12. IPD Sharing Statement

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

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