Epoetin Alfa (Hemax®) Phase IV Study in Chemotherapy Induced Anemia
This study is currently recruiting participants.
Verified December 2012 by Bio Sidus SA
Sponsor:
Bio Sidus SA
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
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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 May 16, 2013