Epoetin Alfa in Advanced Non-Small Cell Lung Cancer (EPO-CAN-20)

Exclusion Criteria

• •1. Systemic platinum-based chemotherapy for lung cancer during the previous two months or planned platinum-based chemotherapy within the next three months;
• •2. Patients previously treated with high dose thoracic radiation (\>10 fractions), or surgery, without objective evidence of disease recurrence;
• •3. Planned high dose thoracic radiation therapy (\>10 fractions);
• •4. A clinically active malignancy, other than the underlying lung cancer which is expected to influence QoL;
• •5. Expected survival of three months or less;
• •6. ECOG Performance status of 3 or 4 (see Appendix D);
• •7. Multiple CNS metastasis or a single CNS lesion that does not demonstrate radiographic stability (Screening CT of head required only if symptomatic, no radiographic follow-up of single resected lesions required);
• •8. Blood transfusions within the last 14 days;
• •9. Previous use of erythropoietin;
• •10. Anemia due to factors other than cancer / radiotherapy (e.g. hemolysis or gastrointestinal bleeding);
• •11. Evidence of untreated folate or vitamin B12 deficiency;
• •12. History of uncontrolled hypertension or diastolic blood pressure greater than 100 mm Hg;
• •13. History of seizure disorder;
• •14. Known hypersensitivity to mammalian cell-derived products, albumin or any component of the study drug;
• •15. Pregnancy, lactation or parturition within the previous 30 days;
• •16. Unwillingness or inability to complete the required QoL questionnaires;
• •17. Mental incompetence, including psychiatric or addictive disorders which would preclude meaningful completion of questionnaires;
• •18. Geographically inaccessible for treatment or follow-up evaluations;
• •19. Currently enrolled in an ongoing therapeutic study;