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

Phase 3

Terminated

• Conditions: Anemia; Lung Cancer; Non-Small-Cell Lung Carcinoma

• Registration Number: NCT00310232
• Lead Sponsor: Ontario Clinical Oncology Group (OCOG)

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2001-02
• Study Completion: 2004-04
• Study First Submitted: 2006-03-31
• Study First Submitted QC: 2006-03-31
• Study First Posted: 2006-04-03
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-01
• Last Update Posted: 2024-04-02

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 70

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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
hemoglobin and hematocrit levels	6 months from randomization
Overall QoL and domain-specific QoL scores	16 weeks following randomization
number of transfusions	6 months from randomization

Trial Locations

Locations (15)

Cross Cancer Institute; 🇨🇦 Edmonton, Alberta, Canada

St. John Regional Hospital; 🇨🇦 St. John, New Brunswick, Canada

Nova Scotia Cancer Centre; 🇨🇦 Halifax, Nova Scotia, Canada

Newfoundland Cancer Treatment & Research Foundation; 🇨🇦 St. John's, Newfoundland and Labrador, Canada

Tom Baker Cancer Centre; 🇨🇦 Calgary, Alberta, Canada

Hamilton Regional Cancer Centre (Juravinski); 🇨🇦 Hamilton, Ontario, Canada

London Regional Cancer Centre; 🇨🇦 London, Ontario, Canada

Princess Margaret Hospital; 🇨🇦 Toronto, Ontario, Canada

Cancer Care Manitoba; 🇨🇦 Winnipeg, Manitoba, Canada

Toronto East General Hospital; 🇨🇦 Toronto, Ontario, Canada

Toronto Sunnybrook Regional Cancer Centre; 🇨🇦 Toronto, Ontario, Canada

Windsor Regional Cancer Centre; 🇨🇦 Windsor, Ontario, Canada

Hotel Dieu Hospital; 🇨🇦 St. Catherines, Ontario, Canada

McGill University Clinical Trials Operations; 🇨🇦 Montreal, Quebec, Canada

Northeastern Ontario Regional Cancer Centre; 🇨🇦 Sudbury, Ontario, Canada