A Safety Study of Epoetin Alfa in Patients With Cancer Who Have Chemotherapy-Related Anemia
Condition: Anemia; Neoplasms
MeSH terms: Anemia
Intervention: Epoetin alfa 450 IU/kg once a week; Epoetin alfa 150 IU/kg 3 times a week; Epoetin alfa 450 IU/kg once a week (QW); Epoetin alfa 150 IU/kg 3 times a week (TIW)
Intervention description: 450 IU/kg once a week by subcutaneous injection preferably in the abdomen for up to 4 weeks after the last dose of chemotherapy for a maximum of 26 weeks.; 150 IU/kg 3 times a week by subcutaneous injection preferably in the abdomen for up to 4 weeks after the last dose of chemotherapy for a maximum of 26 weeks.; 450 IU/kg once a week (QW) by subcutaneous injection preferably in the abdomen for up to 4 weeks after the last dose of chemotherapy for a maximum of 26 weeks; 150 IU/kg 3 times a week (TIW) by subcutaneous injection preferably in the abdomen for up to 4 weeks after the last dose of chemotherapy for a maximum of 26 weeks.
Intervention MeSH terms: Epoetin Alfa
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 504.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Epoetin alfa (EPREX, ERYPO)

Summary:

      The purpose of the study is to evaluate the safety of epoetin alfa in patients with cancer
      who have chemotherapy-related anemia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Any nonmyeloid tumor confirmed by cytology and/or histology

          -  Day 1 baseline hemoglobin (Hb) level <=11 g/dL

          -  Expected to receive at least 12 weeks of chemotherapy after enrollment into the study

          -  Eastern Cooperative Oncology Group (ECOG) performance status <= 2

        Exclusion Criteria:

          -  History of active second cancer except for adequately treated skin cancer and in situ
             (pre-invasive) cervical cancer

          -  History of deep venous thrombosis (DVT) (blood clots in the veins of the thighs or
             legs) or pulmonary embolism (PE) (blood clot in the lungs) within 12 months before
             study entry or at any time if the event is related to the current cancer, which is
             defined as diagnosis of the cancer within 3 months of a DVT/PE episode or a DVT/PE
             following the cancer diagnosis/treatment

          -  History of cardiovascular accident (CVA), transient ischemic attack (TIA) (stroke),
             acute coronary syndrome (ACS) (a condition indicating damage to the heart), or other
             arterial thrombosis (blood clots) within 6 months before study entry

          -  Onset of seizures within 3 months before randomization or poorly controlled seizures

          -  Brain tumor or brain metastasis from another malignancy or cardiac disease that is
             markedly or completely limiting, uncontrolled hypertension (high blood pressure), or
             anemia (a lack of red blood cells in the blood) for reasons other than cancer or
             chemotherapy

          -  Specifically excluded concomitant medications or therapies including prophylactic
             anticoagulation therapy for recurrence of prior thrombovascular event (TVE) (warfarin,
             unfractionated heparin, low molecular weight heparin [LMWH], except for prevention of
             central venous catheter thrombosis at doses specified in the protocol, direct thrombin
             inhibitors, or anti-platelet drugs [e.g., clopidogrel or ticlopidine]), except for
             prophylaxis in patients with known cardiovascular disease