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Randomized Trial of Epoetin Alfa in Patients With Advanced Non-Small Cell Carcinoma of the Lung (EPO-CAN-20)

Phase 3
18 Years
Not Enrolling
Non-Small-Cell Lung Carcinoma, Lung Cancer, Anemia

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Trial Information

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

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;

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Outcome Measure:

Change in anemia and fatigue related QoL at 12 weeks following randomization

Outcome Time Frame:

12 weeks following randomization

Principal Investigator

Jim Wright, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Hamilton Regional Cancer Centre


Canada: Health Canada

Study ID:




Start Date:

February 2001

Completion Date:

April 2004

Related Keywords:

  • Non-Small-Cell Lung Carcinoma
  • Lung Cancer
  • Anemia
  • Quality of Life
  • Blood transfusion
  • Anemia
  • Carcinoma
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms