Status:
TERMINATED
Epoetin Alfa in Advanced Non-Small Cell Lung Cancer (EPO-CAN-20)
Lead Sponsor:
Ontario Clinical Oncology Group (OCOG)
Collaborating Sponsors:
Ortho Biotech, Inc.
Conditions:
Non-Small-Cell Lung Carcinoma
Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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...
Eligibility Criteria
Inclusion
- 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
- Hemoglobin level at or below 120 g/L; and
- At least 18 years of age;
Exclusion
- Systemic platinum-based chemotherapy for lung cancer during the previous two months or planned platinum-based chemotherapy within the next three months;
- Patients previously treated with high dose thoracic radiation (\>10 fractions), or surgery, without objective evidence of disease recurrence;
- Planned high dose thoracic radiation therapy (\>10 fractions);
- A clinically active malignancy, other than the underlying lung cancer which is expected to influence QoL;
- Expected survival of three months or less;
- ECOG Performance status of 3 or 4 (see Appendix D);
- 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);
- Blood transfusions within the last 14 days;
- Previous use of erythropoietin;
- Anemia due to factors other than cancer / radiotherapy (e.g. hemolysis or gastrointestinal bleeding);
- Evidence of untreated folate or vitamin B12 deficiency;
- History of uncontrolled hypertension or diastolic blood pressure greater than 100 mm Hg;
- History of seizure disorder;
- Known hypersensitivity to mammalian cell-derived products, albumin or any component of the study drug;
- Pregnancy, lactation or parturition within the previous 30 days;
- Unwillingness or inability to complete the required QoL questionnaires;
- Mental incompetence, including psychiatric or addictive disorders which would preclude meaningful completion of questionnaires;
- Geographically inaccessible for treatment or follow-up evaluations;
- Currently enrolled in an ongoing therapeutic study;
Key Trial Info
Start Date :
February 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2004
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT00310232
Start Date
February 1 2001
End Date
April 1 2004
Last Update
April 2 2024
Active Locations (15)
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1
Tom Baker Cancer Centre
Calgary, Alberta, Canada, T2N 4N2
2
Cross Cancer Institute
Edmonton, Alberta, Canada, T6G 1Z2
3
Cancer Care Manitoba
Winnipeg, Manitoba, Canada, R3E 0V9
4
St. John Regional Hospital
Saint John, New Brunswick, Canada, E2L 4L2