Randomized Trial of Epoetin Alfa in Patients With Advanced Non-Small Cell Carcinoma of the Lung (EPO-CAN-20)
Inclusion Criteria:
1. Histologically confirmed non-small cell lung cancer (squamous cell, large cell,
adenocarcinoma, or some combination of these), with clinical or pathological stage
III or IV, or recurrent disease; and
2. Hemoglobin level at or below 120 g/L; and
3. At least 18 years of age;
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;