Antineoplastic Chemotherapy Induced Anemia Clinical Trial
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
| Verified date | April 2016 |
| Source | Bio Sidus SA |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Argentina: Ministry of Health |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 30 |
| Est. completion date | November 2014 |
| Est. primary completion date | November 2014 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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 |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Argentina | Centro Oncologico de Investigaciones Buenos Aires | Berazategui | Buenos Aires |
| Argentina | Centro de Medicina Integral e Investigación Clínica | Buenos Aires | |
| Argentina | Hospital Zonal Especializado en Oncología de Lanus | Lanus Este | Buenos Aires |
| Lead Sponsor | Collaborator |
|---|---|
| Bio Sidus SA | IC RESEARCH GROUP |
Argentina,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Number of subjects with adverse events and percentage of therapy withdrawals due to treatment emergent adverse events | Baseline to 12 weeks | Yes | |
| Secondary | 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 | Every 4 weeks and 12 weeks | No |
| Secondary | 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 | 12 Weeks | No |
| Secondary | 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 | 12 weeks | No |