Clinical trial NCT00310232: Epoetin Alfa in Advanced Non-Small Cell Lung Cancer (EPO-CAN-20)
Official title: Randomized Trial of Epoetin Alfa in Patients With Advanced Non-Small Cell Carcinoma of the Lung (EPO-CAN-20)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Non-Small-Cell Lung Carcinoma
Lung Cancer
Anemia
Keywords: Quality of Life
Blood transfusion
Lead sponsor: Ontario Clinical Oncology Group (OCOG)
Sponsor class: OTHER
Collaborators: name: Ortho Biotech, Inc.
First posted: 2006-04-03
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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;

Primary outcomes:
measure: Change in anemia and fatigue related QoL at 12 weeks following randomization
timeFrame: 12 weeks following randomization
Secondary outcomes:
measure: Overall QoL and domain-specific QoL scores
timeFrame: 16 weeks following randomization
measure: hemoglobin and hematocrit levels
timeFrame: 6 months from randomization
measure: number of transfusions
timeFrame: 6 months from randomization
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Tom Baker Cancer Centre
state: Alberta
city: Edmonton
country: Canada
facility: Cross Cancer Institute
state: Alberta
city: Winnipeg
country: Canada
facility: Cancer Care Manitoba
state: Manitoba
city: St. John
country: Canada
facility: St. John Regional Hospital
state: New Brunswick
city: St. John's
country: Canada
facility: Newfoundland Cancer Treatment & Research Foundation
state: Newfoundland and Labrador
city: Halifax
country: Canada
facility: Nova Scotia Cancer Centre
state: Nova Scotia
city: Hamilton
country: Canada
facility: Hamilton Regional Cancer Centre (Juravinski)
state: Ontario
city: London
country: Canada
facility: London Regional Cancer Centre
state: Ontario
city: St. Catherines
country: Canada
facility: Hotel Dieu Hospital
state: Ontario
city: Sudbury
country: Canada
facility: Northeastern Ontario Regional Cancer Centre
state: Ontario
city: Toronto
country: Canada
facility: Toronto East General Hospital
state: Ontario
city: Toronto
country: Canada
facility: Toronto Sunnybrook Regional Cancer Centre
state: Ontario
city: Toronto
country: Canada
facility: Princess Margaret Hospital
state: Ontario
city: Windsor
country: Canada
facility: Windsor Regional Cancer Centre
state: Ontario
city: Montreal
country: Canada
facility: McGill University Clinical Trials Operations
state: Quebec
Study officials:
affiliation: Hamilton Regional Cancer Centre
name: Jim Wright, MD
role: STUDY_CHAIR
affiliation: Ontarion Clinical Oncology Group
name: Mark Levine, MD
role: STUDY_DIRECTOR
References:
citation: 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-related anemia. J Clin Oncol. 2007 Mar 20;25(9):1027-32. doi: 10.1200/JCO.2006.07.1514. Epub 2007 Feb 20.