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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00310232
Recruitment Status : Terminated (Recommendation of DSMB for safety issue, increased mortality with study drug.)
First Posted : April 3, 2006
Last Update Posted : July 3, 2007
Ortho Biotech Products, L.P.
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Non-Small-Cell Lung Carcinoma Lung Cancer Anemia Drug: Epoetin Alfa Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Randomized Trial of Epoetin Alfa in Patients With Advanced Non-Small Cell Carcinoma of the Lung (EPO-CAN-20)
Study Start Date : February 2001
Actual Study Completion Date : April 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anemia

Primary Outcome Measures :
  1. Change in anemia and fatigue related QoL at 12 weeks following randomization [ Time Frame: 12 weeks following randomization ]

Secondary Outcome Measures :
  1. Overall QoL and domain-specific QoL scores [ Time Frame: 16 weeks following randomization ]
  2. hemoglobin and hematocrit levels [ Time Frame: 6 months from randomization ]
  3. number of transfusions [ Time Frame: 6 months from randomization ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00310232

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Canada, Alberta
Tom Baker Cancer Centre
Calgary, Alberta, Canada, T2N 4N2
Cross Cancer Institute
Edmonton, Alberta, Canada, T6G 1Z2
Canada, Manitoba
Cancer Care Manitoba
Winnipeg, Manitoba, Canada, R3E 0V9
Canada, New Brunswick
St. John Regional Hospital
St. John, New Brunswick, Canada, E2L 4L2
Canada, Newfoundland and Labrador
Newfoundland Cancer Treatment & Research Foundation
St. John's, Newfoundland and Labrador, Canada, A1B 3V6
Canada, Nova Scotia
Nova Scotia Cancer Centre
Halifax, Nova Scotia, Canada, B3H 1V7
Canada, Ontario
Hamilton Regional Cancer Centre (Juravinski)
Hamilton, Ontario, Canada, L8V 5C2
London Regional Cancer Centre
London, Ontario, Canada, N6A 4L6
Hotel Dieu Hospital
St. Catherines, Ontario, Canada, L2K 5K3
Northeastern Ontario Regional Cancer Centre
Sudbury, Ontario, Canada, P3E 5J1
Toronto East General Hospital
Toronto, Ontario, Canada, M4C 3E7
Toronto Sunnybrook Regional Cancer Centre
Toronto, Ontario, Canada, M4N 3M5
Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
Windsor Regional Cancer Centre
Windsor, Ontario, Canada, N8W 2X3
Canada, Quebec
McGill University Clinical Trials Operations
Montreal, Quebec, Canada, H2W 1S6
Sponsors and Collaborators
Ontario Clinical Oncology Group (OCOG)
Ortho Biotech Products, L.P.
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Study Chair: Jim Wright, MD Hamilton Regional Cancer Centre
Study Director: Mark Levine, MD Ontarion Clinical Oncology Group
Publications of Results:
Layout table for additonal information Identifier: NCT00310232    
Other Study ID Numbers: CTA-Control-076080
HC File 9427-J0921-22C
First Posted: April 3, 2006    Key Record Dates
Last Update Posted: July 3, 2007
Last Verified: March 2006
Keywords provided by Ontario Clinical Oncology Group (OCOG):
Quality of Life
Blood transfusion
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Epoetin Alfa