Epoetin Alfa (Hemax®) Phase IV Study in Chemotherapy Induced Anemia

A Phase 4 Study in the Treatment of Anemia With Weekly Epoetin Alfa Doses in Patients With Solid Tumors or Lymphoma Receiving Chemotherapy

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.

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