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

Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00310232
• Other study ID #: CTA-Control-076080
• Secondary ID: HC File 9427-J09
• Status: Terminated
• Phase: Phase 3
• Start date: February 2001
• Est. completion date: April 2004

Study information

• Verified date: April 2024
• Source: Ontario Clinical Oncology Group (OCOG)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The general objective of this study is to improve the Quality of Life (QoL) of selected patients with advanced carcinoma of the lung. The specific objective is to evaluate the effect of treatment with epoetin alfa (recombinant human erythropoietin) on anemia related QoL and anemia in non-small cell lung cancer patients with advanced stage disease and underlying anemia of malignancy.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 70
• Est. completion date: April 2004
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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;

Related Conditions & MeSH terms

• Anemia
• Carcinoma
• Carcinoma, Non-Small-Cell Lung
• Lung Cancer
• Lung Neoplasms
• Non-Small-Cell Lung Carcinoma

Intervention

Drug:
• Epoetin Alfa

Locations

Country	Name	City	State
Canada	Tom Baker Cancer Centre	Calgary	Alberta
Canada	Cross Cancer Institute	Edmonton	Alberta
Canada	Nova Scotia Cancer Centre	Halifax	Nova Scotia
Canada	Hamilton Regional Cancer Centre (Juravinski)	Hamilton	Ontario
Canada	London Regional Cancer Centre	London	Ontario
Canada	McGill University Clinical Trials Operations	Montreal	Quebec
Canada	Hotel Dieu Hospital	St. Catherines	Ontario
Canada	St. John Regional Hospital	St. John	New Brunswick
Canada	Newfoundland Cancer Treatment & Research Foundation	St. John's	Newfoundland and Labrador
Canada	Northeastern Ontario Regional Cancer Centre	Sudbury	Ontario
Canada	Princess Margaret Hospital	Toronto	Ontario
Canada	Toronto East General Hospital	Toronto	Ontario
Canada	Toronto Sunnybrook Regional Cancer Centre	Toronto	Ontario
Canada	Windsor Regional Cancer Centre	Windsor	Ontario
Canada	Cancer Care Manitoba	Winnipeg	Manitoba

Sponsors (2)

Lead Sponsor	Collaborator
Ontario Clinical Oncology Group (OCOG)	Ortho Biotech, Inc.

Country where clinical trial is conducted

Canada, 

References & Publications (1)

Wright JR, Ung YC, Julian JA, Pritchard KI, Whelan TJ, Smith C, Szechtman B, Roa W, Mulroy L, Rudinskas L, Gagnon B, Okawara GS, Levine MN. Randomized, double-blind, placebo-controlled trial of erythropoietin in non-small-cell lung cancer with disease-rel — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in anemia and fatigue related QoL at 12 weeks following randomization		12 weeks following randomization
Secondary	Overall QoL and domain-specific QoL scores		16 weeks following randomization
Secondary	hemoglobin and hematocrit levels		6 months from randomization
Secondary	number of transfusions		6 months from randomization