A Phase 4 Study in the Treatment of Anemia With Weekly Epoetin Alfa Doses in Patients With Solid Tumors or Lymphoma Receiving Chemotherapy
18 Years
N/A
Both
Antineoplastic Chemotherapy Induced Anemia
Trial Information
A Phase 4 Study in the Treatment of Anemia With Weekly Epoetin Alfa Doses in Patients With Solid Tumors or Lymphoma Receiving Chemotherapy
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.
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
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Number of subjects with adverse events and percentage of therapy withdrawals due to treatment emergent adverse events
Outcome Time Frame:
Baseline to 12 weeks
Safety Issue:
Yes
Principal Investigator
Roberto Diez, MD
Investigator Role:
Study Director
Investigator Affiliation:
Bio Sidus SA
Authority:
Argentina: Ministry of Health
Study ID:
BIOS-012010
NCT ID:
NCT01374373
Start Date:
June 2011
Completion Date:
July 2013
Related Keywords:
- Antineoplastic Chemotherapy Induced Anemia
- Chemotherapy
- Anemia
- Epoetin alfa
- Erythropoiesis stimulating agent (ESA)
- Anemia
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