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

April 1, 2024 updated by: Ontario Clinical Oncology Group (OCOG)

Randomized Trial of Epoetin Alfa in Patients With Advanced Non-Small Cell Carcinoma of the Lung (EPO-CAN-20)

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

70

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 4N2
        • Tom Baker Cancer Centre
      • Edmonton, Alberta, Canada, T6G 1Z2
        • Cross Cancer Institute
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3E 0V9
        • Cancer Care Manitoba
    • New Brunswick
      • St. John, New Brunswick, Canada, E2L 4L2
        • St. John Regional Hospital
    • Newfoundland and Labrador
      • St. John's, Newfoundland and Labrador, Canada, A1B 3V6
        • Newfoundland Cancer Treatment & Research Foundation
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 1V7
        • Nova Scotia Cancer Centre
    • Ontario
      • Hamilton, Ontario, Canada, L8V 5C2
        • Hamilton Regional Cancer Centre (Juravinski)
      • London, Ontario, Canada, N6A 4L6
        • London Regional Cancer Centre
      • St. Catherines, Ontario, Canada, L2K 5K3
        • Hotel Dieu Hospital
      • Sudbury, Ontario, Canada, P3E 5J1
        • Northeastern Ontario Regional Cancer Centre
      • Toronto, Ontario, Canada, M4C 3E7
        • Toronto East General Hospital
      • Toronto, Ontario, Canada, M4N 3M5
        • Toronto Sunnybrook Regional Cancer Centre
      • Toronto, Ontario, Canada, M5G 2M9
        • Princess Margaret Hospital
      • Windsor, Ontario, Canada, N8W 2X3
        • Windsor Regional Cancer Centre
    • Quebec
      • Montreal, Quebec, Canada, H2W 1S6
        • McGill University Clinical Trials Operations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in anemia and fatigue related QoL at 12 weeks following randomization
Time Frame: 12 weeks following randomization
12 weeks following randomization

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ontario Clinical Oncology Group (OCOG)

Collaborators

Ortho Biotech, Inc.

Investigators

  • Study Chair: Jim Wright, MD, Hamilton Regional Cancer Centre
  • Study Director: Mark Levine, MD, Ontarion Clinical Oncology Group

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2001

Study Completion (Actual)

April 1, 2004

Study Registration Dates

First Submitted

March 31, 2006

First Submitted That Met QC Criteria

March 31, 2006

First Posted (Estimated)

April 3, 2006

Study Record Updates

Last Update Posted (Actual)

April 2, 2024

Last Update Submitted That Met QC Criteria

April 1, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CTA-Control-076080
  • HC File 9427-J0921-22C

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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