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

This study has been terminated.
(Recommendation of DSMB for safety issue, increased mortality with study drug.)
Sponsor:
Collaborator:
Ortho Biotech Products, L.P.
Information provided by:
Ontario Clinical Oncology Group (OCOG)
ClinicalTrials.gov Identifier:
NCT00310232
First received: March 31, 2006
Last updated: June 29, 2007
Last verified: March 2006
  Purpose

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 Intervention Phase
Non-Small-Cell Lung Carcinoma
Lung Cancer
Anemia
Drug: Epoetin Alfa
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Randomized Trial of Epoetin Alfa in Patients With Advanced Non-Small Cell Carcinoma of the Lung (EPO-CAN-20)

Resource links provided by NLM:


Further study details as provided by Ontario Clinical Oncology Group (OCOG):

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

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

Enrollment: 70
Study Start Date: February 2001
Study Completion Date: April 2004
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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;
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00310232

Locations
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
Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
Toronto East General Hospital
Toronto, Ontario, Canada, M4C 3E7
Toronto Sunnybrook Regional Cancer Centre
Toronto, Ontario, Canada, M4N 3M5
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.
Investigators
Study Chair: Jim Wright, MD Hamilton Regional Cancer Centre
Study Director: Mark Levine, MD Ontarion Clinical Oncology Group
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00310232     History of Changes
Other Study ID Numbers: CTA-Control-076080, HC File 9427-J0921-22C
Study First Received: March 31, 2006
Last Updated: June 29, 2007
Health Authority: Canada: Health Canada

Keywords provided by Ontario Clinical Oncology Group (OCOG):
Quality of Life
Blood transfusion

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Epoetin alfa
Hematinics
Hematologic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 22, 2014