Non-Small-Cell Lung CarcinomaPhase 3NCT00310232
Epoetin Alfa in Advanced Non-Small Cell Lung Cancer (EPO-CAN-20)
A Phase 3 study testing Epoetin Alfa in people with Non-Small-Cell Lung Carcinoma and Lung Cancer, run by Ontario Clinical Oncology Group (OCOG) at 15 sites in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Small-Cell Lung Carcinoma, Lung Cancer, Anemia
- What is being tested?
- Epoetin Alfa
- How many people
- 70 participants
- Where
- 15 sitesCanada
- Study dates
- Feb 2001to Apr 2004
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
Who cannot join
- 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);
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- 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;
- Unwillingness or inability to complete the required QoL questionnaires;
- Mental incompetence, including psychiatric or addictive disorders which would preclude meaningful completion of questionnaires;
- Geographically inaccessible for treatment or follow-up evaluations;
- Currently enrolled in an ongoing therapeutic study;
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
Canada15 sites
Tom Baker Cancer Centre
Calgary, Alberta, T2N 4N2
Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2
Northeastern Ontario Regional Cancer Centre
Greater Sudbury, Ontario, P3E 5J1
Nova Scotia Cancer Centre
Halifax, Nova Scotia, B3H 1V7
Hamilton Regional Cancer Centre (Juravinski)
Hamilton, Ontario, L8V 5C2
London Regional Cancer Centre
London, Ontario, N6A 4L6
McGill University Clinical Trials Operations
Montreal, Quebec, H2W 1S6
Hotel Dieu Hospital
Saint Catherines, Ontario, L2K 5K3
St. John Regional Hospital
Saint John, New Brunswick, E2L 4L2
Newfoundland Cancer Treatment & Research Foundation
St. John's, Newfoundland and Labrador, A1B 3V6
Toronto East General Hospital
Toronto, Ontario, M4C 3E7
Toronto Sunnybrook Regional Cancer Centre
Toronto, Ontario, M4N 3M5
Princess Margaret Hospital
Toronto, Ontario, M5G 2M9
Windsor Regional Cancer Centre
Windsor, Ontario, N8W 2X3
Cancer Care Manitoba
Winnipeg, Manitoba, R3E 0V9
About this study
Official title: 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.
- Conditions
- Non-Small-Cell Lung Carcinoma, Lung Cancer, Anemia
- Being tested
- Epoetin Alfa
- Keywords
- Quality of Life, Blood transfusion
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Lung Neoplasms, Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Epoetin AlfaDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in anemia and fatigue related QoL at 12 weeks following randomization
Measured: 12 weeks following randomization
Secondary outcomes (3)
Overall QoL and domain-specific QoL scores
Measured: 16 weeks following randomization
hemoglobin and hematocrit levels
Measured: 6 months from randomization
number of transfusions
Measured: 6 months from randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2006 (estimated)
- Study startFeb 2001
- Study completionApr 2004
Why it stopped: Recommendation of DSMB for safety issue, increased mortality with study drug.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non-Small-Cell Lung CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ontario Clinical Oncology Group (OCOG)
- Sponsor type
- University, hospital or other
- Collaborators
- Ortho Biotech, Inc.
- Investigators
- Jim Wright, MD, Study chair, Hamilton Regional Cancer CentreMark Levine, MD, Study director, Ontarion Clinical Oncology Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00310232
- Sponsor's protocol ID
- CTA-Control-076080
- Other IDs
- HC File 9427-J0921-22C
- Status last verified
- Apr 2024
- First submitted
- 31 Mar 2006
- Last updated
- 2 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 17312332
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial of Epoetin Alfa in Patients With Advanced Non-Small Cell Carcinoma of the Lung (EPO-CAN-20)
- ClinicalTrials.gov ID
- NCT00310232
- Acronym / sponsor ID
- CTA-Control-076080
- Conditions
- Non-Small-Cell Lung Carcinoma, Lung Cancer, Anemia
- Keywords
- Quality of Life, Blood transfusion
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recommendation of DSMB for safety issue, increased mortality with study drug.
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Ontario Clinical Oncology Group (OCOG)University, hospital or other
- Collaborators
- Ortho Biotech, Inc.
- Study start
- Feb 2001
- Study completion
- Apr 2004 (actual)
- First posted
- 3 Apr 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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;
Key exclusion criteria (19 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Epoetin Alfa | Drug | – |
Primary outcome
Change in anemia and fatigue related QoL at 12 weeks following randomization
Time frame: 12 weeks following randomization
3 secondary outcomes
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
Results and safety
The study was stopped early (reason given: Recommendation of DSMB for safety issue, increased mortality with study drug.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2024.
- Results publication: PubMed 17312332Wright 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jim Wright, MD study chair
Hamilton Regional Cancer Centre
Mark Levine, MD study director
Ontarion Clinical Oncology Group
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Epoetin Alfa in people with Non-Small-Cell Lung Carcinoma and Lung Cancer, run by Ontario Clinical Oncology Group (OCOG) at 15 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 2 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Recommendation of DSMB for safety issue, increased mortality with study drug.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in anemia and fatigue related QoL at 12 weeks following randomization (time frame: 12 weeks following randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00310232, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2024; AzTrials last refreshed its copy on 7 Nov 2026.