Epoetin Alfa (Hemax®) Phase IV Study in Chemotherapy Induced Anemia
Information source: Bio Sidus SA
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Antineoplastic Chemotherapy Induced Anemia
Intervention: Epoetin alfa (Biological)
Phase: Phase 4
Status: Recruiting
Sponsored by: Bio Sidus SA Official(s) and/or principal investigator(s): Roberto Diez, MD, Study Director, Affiliation: Bio Sidus SA
Overall contact: Roberto Diez, MD, Phone: 5411-4909-8049, Email: r.diez@biosidus.com.ar
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.
Clinical Details
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 design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Number of subjects with adverse events and percentage of therapy withdrawals due to treatment emergent adverse events
Secondary outcome: Hemoglobin levels and percentage of respondersQuality of life Hemoglobin levels ≥ 2 g/dl
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
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Roberto Diez, MD, Phone: 5411-4909-8049, Email: r.diez@biosidus.com.ar
Centro de Medicina Integral e Investigación ClÃnica, Buenos Aires, Argentina; Recruiting Carlos Guzman Machado, MD
Centro Oncologico de Investigaciones Buenos Aires, Berazategui, Buenos Aires, Argentina; Recruiting Mirta Varela, MD
Hospital Zonal Especializado en OncologÃa de Lanus, Lanus Este, Buenos Aires CP 1824, Argentina; Recruiting Eduardo Diez, MD, Phone: 5411-4241-2968, Email: terapeutica.lanus@yahoo.com.ar
Additional Information
Starting date: June 2011
Last updated: December 13, 2012
|