Clinical trial NCT01374373: Epoetin Alfa (Hemax®) Phase IV Study in Chemotherapy Induced Anemia
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Antineoplastic Chemotherapy Induced Anemia
Keywords: Chemotherapy
Anemia
Epoetin alfa
Erythropoiesis stimulating agent (ESA)
Lead sponsor: Bio Sidus SA
Sponsor class: INDUSTRY
Collaborators: name: IC RESEARCH GROUP
First posted: 2011-06-16
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Number of subjects with adverse events and percentage of therapy withdrawals due to treatment emergent adverse events
timeFrame: Baseline to 12 weeks
Secondary outcomes:
measure: Hemoglobin levels and percentage of responders
timeFrame: Every 4 weeks and 12 weeks
measure: Quality of life
timeFrame: 12 Weeks
measure: Hemoglobin levels ≥ 2 g/dl
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Berazategui
country: Argentina
facility: Centro Oncologico de Investigaciones Buenos Aires
state: Buenos Aires
city: Lanus Este
country: Argentina
facility: Hospital Zonal Especializado en Oncología de Lanus
state: Buenos Aires
city: Buenos Aires
country: Argentina
facility: Centro de Medicina Integral e Investigación Clínica
Study officials:
affiliation: Bio Sidus SA
name: Roberto Diez, MD
role: STUDY_DIRECTOR
References: