Antineoplastic Chemotherapy Induced Anemia
Conditions
Keywords
Chemotherapy, Anemia, Epoetin alfa, Erythropoiesis stimulating agent (ESA)
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.
Interventions
BIOLOGICALEpoetin 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
Sponsors
IC RESEARCH GROUP
Bio Sidus SA
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of subjects with adverse events and percentage of therapy withdrawals due to treatment emergent adverse events | Baseline to 12 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hemoglobin levels and percentage of responders | 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 |
| Quality of life | 12 Weeks | 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 | 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 |
Countries
Argentina
Outcome results
None listed