Study Stopped
Recommendation of DSMB for safety issue, increased mortality with study drug.
Epoetin Alfa in Advanced Non-Small Cell Lung Cancer (EPO-CAN-20)
Randomized Trial of Epoetin Alfa in Patients With Advanced Non-Small Cell Carcinoma of the Lung (EPO-CAN-20)
2 other identifiers
interventional
70
1 country
15
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Feb 2001
Typical duration for phase_3
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2001
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2004
CompletedFirst Submitted
Initial submission to the registry
March 31, 2006
CompletedFirst Posted
Study publicly available on registry
April 3, 2006
CompletedApril 2, 2024
April 1, 2024
March 31, 2006
April 1, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in anemia and fatigue related QoL at 12 weeks following randomization
12 weeks following randomization
Secondary Outcomes (3)
Overall QoL and domain-specific QoL scores
16 weeks following randomization
hemoglobin and hematocrit levels
6 months from randomization
number of transfusions
6 months from randomization
Interventions
Eligibility Criteria
You may qualify if:
- 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;
You may not qualify if:
- 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;
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ontario Clinical Oncology Group (OCOG)lead
- Ortho Biotech, Inc.collaborator
Study Sites (15)
Tom Baker Cancer Centre
Calgary, Alberta, T2N 4N2, Canada
Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2, Canada
Cancer Care Manitoba
Winnipeg, Manitoba, R3E 0V9, Canada
St. John Regional Hospital
Saint John, New Brunswick, E2L 4L2, Canada
Newfoundland Cancer Treatment & Research Foundation
St. John's, Newfoundland and Labrador, A1B 3V6, Canada
Nova Scotia Cancer Centre
Halifax, Nova Scotia, B3H 1V7, Canada
Northeastern Ontario Regional Cancer Centre
Greater Sudbury, Ontario, P3E 5J1, Canada
Hamilton Regional Cancer Centre (Juravinski)
Hamilton, Ontario, L8V 5C2, Canada
London Regional Cancer Centre
London, Ontario, N6A 4L6, Canada
Hotel Dieu Hospital
Saint Catherines, Ontario, L2K 5K3, Canada
Toronto East General Hospital
Toronto, Ontario, M4C 3E7, Canada
Toronto Sunnybrook Regional Cancer Centre
Toronto, Ontario, M4N 3M5, Canada
Princess Margaret Hospital
Toronto, Ontario, M5G 2M9, Canada
Windsor Regional Cancer Centre
Windsor, Ontario, N8W 2X3, Canada
McGill University Clinical Trials Operations
Montreal, Quebec, H2W 1S6, Canada
Related 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-related anemia. J Clin Oncol. 2007 Mar 20;25(9):1027-32. doi: 10.1200/JCO.2006.07.1514. Epub 2007 Feb 20.
PMID: 17312332RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Jim Wright, MD
Hamilton Regional Cancer Centre
- STUDY DIRECTOR
Mark Levine, MD
Ontarion Clinical Oncology Group
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
March 31, 2006
First Posted
April 3, 2006
Study Start
February 1, 2001
Study Completion
April 1, 2004
Last Updated
April 2, 2024
Record last verified: 2024-04