AnemiaPhase 4NCT00216541
A Study of the Safety and Effectiveness of Epoetin Alfa on Hemoglobin Levels and Blood Transfusions in Cancer Patients Receiving Chemotherapy
A Phase 4 study testing epoetin alfa in people with Anemia and Neoplasms, run by Janssen-Cilag B.V..
Trial summary
The purpose of this study is to evaluate the effect of early treatment with epoetin alfa in addition to best standard of care on hemoglobin levels and the need for red blood cell transfusions in cancer patients receiving chemotherapy as compared to patients receiving standard epoetin alfa treatment and best standard… Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- epoetin alfa
- How many people
- 110 participants
- Where
- No sites listed yet
- Study dates
- Aug 2003to Sep 2006
- Phase
- Phase 4
- 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
- Confirmed diagnosis of cancer and planned to receive chemotherapy in 1, 2, 3, or 4 weekly schedules for a minimum of 8 weeks
- have a hemoglobin level of >10 grams per deciliter and <= 12 grams per deciliter within 14 days before the start of the first on-study chemotherapy cycle
- Eastern Cooperative Oncology Group (scale used by researchers to represent the level of activity a patient is capable of) score of 0 (able to carry out all normal activity without restriction) to 2 (ambulatory and capable of all self-care but unable to carry out any work)
- life expectancy of >=6 months
- female subjects postmenopausal for at least 1 year, surgically sterile or practicing an effective method of birth control
Who cannot join
- Clinically significant or uncontrolled disease/dysfunction of any body system that is not due to cancer or chemotherapy, including uncontrolled or severe cardiovascular disease, recent (< 6 months) myocardial infarction, uncontrolled high blood pressure, congestive heart failure, or uncontrolled or unexplained history of seizures
- planned surgery expected to influence hemoglobin levels, within the first 8 or 9 weeks of study entry
- major illness or infection within 1 month of study entry
- highly increased risk of thrombotic or other vascular events
- androgen therapy within 2 months of study entry
- anemia due to factors other than cancer/chemotherapy (e.g., severe hemolysis, gastrointestinal bleeding, or myelodysplastic syndromes)
- blood transfusion within 14 days prior to study entry
- pregnant or lactating females
About this study
Official title: Randomised Study to Evaluate the Effect of Early Intervention to Treat Anemia With Epoetin Alfa Versus Standard Use on Hemoglobin Levels and the Incidence of Blood Transfusions in Cancer Patients Receiving Chemotherapy
The purpose of this study is to evaluate the effect of early treatment with epoetin alfa in addition to best standard of care on hemoglobin levels and the need for red blood cell transfusions in cancer patients receiving chemotherapy as compared to patients receiving standard epoetin alfa treatment and best standard of care.
Read the detailed description
Cancer patients often experience anemia due to the disease itself, chemotherapy, or both. Quality of life is also affected, due in part to the tiredness associated with anemia. Previous studies with epoetin alfa have suggested that early intervention with epoetin alfa results in higher hemoglobin levels and lower incidence of red blood cell transfusions than are achieved with delayed intervention. This is a randomized, open-label, explorative, sequential study that evaluates the effects of early treatment with epoetin alfa to determine its impact on hemoglobin values and the need for red blood cell transfusions as well as the safety of epoetin alfa when used in the prevention of anemia during chemotherapy in adult patients with cancer. During their current course of chemotherapy, patients will receive either early treatment with epoetin alfa or standard treatment with epoetin alfa (epoetin alfa administered when hemoglobin is <=10 g/dL), in addition to best standard care. Best standard care during chemotherapy may include red blood cell transfusions, white cell growth factors, folic acid, and iron supplementation, as needed. Effectiveness will be determined by the number of patients who receive an allogenic blood transfusion during the study and the change in hemoglobin at 3 or 4 weeks, 8 or 9 weeks, and 12 weeks, and at the end of the treatment period. Safety evaluations (incidence of adverse events, abnormal clinical laboratory tests, and vital signs) will be performed throughout the study. The study hypothesis is that cancer patients receiving chemotherapy who receive early treatment with epoetin alfa will have higher hemoglobin levels and fewer red blood cell transfusions than cancer patients receiving chemotherapy who receive standard treatment with epoetin alfa. This study will be conducted in the Netherlands and will only enroll European patients and will be generally well-tolerated. Epoetin alfa injections (40,000 units) under skin once a week either within 7 days after start of first chemotherapy cycle or from day hemoglobin is <=10 g/dL. Patients will receive epoetin alfa during the current course of chemotherapy or up to 24 weeks. Dose may be adjusted.
- Being tested
- epoetin alfa
- Keywords
- Anemia, cancer, transfusion, chemotherapy, hemoglobin, standard care, epoetin alfa, epoetin, erythropoietin
- Medical subject headings
- Anemia, Neoplasms
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 hemoglobin from the start of the study to 3 or 4, 8 or 9, and 12 weeks, and at the end of the treatment period
Secondary outcomes (1)
Number of patients who receive an allogenic blood transfusion during the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startAug 2003
- Study completionSep 2006
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 AnemiaStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen-Cilag B.V.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Janssen-Cilag B.V. Clinical Trial, Study director, Janssen-Cilag B.V.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00216541
- Sponsor's protocol ID
- CR003541
- Status last verified
- Jun 2010
- First submitted
- 13 Sep 2005
- Last updated
- 19 May 2011
- Results posted
- No
Publications
Schouwink JH, Codrington H, Sleeboom HP, Kerkhofs LG, Wormhoudt LW. Prevention of anaemia by early intervention with once weekly epoetin alfa during chemotherapy. Eur J Cancer. 2008 Apr;44(6):819-29. doi: 10.1016/j.ejca.2008.02.017. Epub 2008 Mar 17.
PubMed 18343652
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised Study to Evaluate the Effect of Early Intervention to Treat Anemia With Epoetin Alfa Versus Standard Use on Hemoglobin Levels and the Incidence of Blood Transfusions in Cancer Patients Receiving Chemotherapy
- ClinicalTrials.gov ID
- NCT00216541
- Acronym / sponsor ID
- CR003541
- Keywords
- Anemia, cancer, transfusion, chemotherapy, hemoglobin, standard care, epoetin alfa, epoetin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Janssen-Cilag B.V.Industry (pharma, biotech, devices)
- Study start
- Aug 2003
- Study completion
- Sep 2006 (actual)
- First posted
- 22 Sep 2005 (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 purpose of this study is to evaluate the effect of early treatment with epoetin alfa in addition to best standard of care on hemoglobin levels and the need for red blood cell transfusions in cancer patients receiving chemotherapy as compared to patients receiving standard epoetin alfa treatment and best standard of care.
Detailed description
Cancer patients often experience anemia due to the disease itself, chemotherapy, or both. Quality of life is also affected, due in part to the tiredness associated with anemia. Previous studies with epoetin alfa have suggested that early intervention with epoetin alfa results in higher hemoglobin levels and lower incidence of red blood cell transfusions than are achieved with delayed intervention. This is a randomized, open-label, explorative, sequential study that evaluates the effects of early treatment with epoetin alfa to determine its impact on hemoglobin values and the need for red blood cell transfusions as well as the safety of epoetin alfa when used in the prevention of anemia during chemotherapy in adult patients with cancer. During their current course of chemotherapy, patients will receive either early treatment with epoetin alfa or standard treatment with epoetin alfa (epoetin alfa administered when hemoglobin is <=10 g/dL), in addition to best standard care. Best standard care during chemotherapy may include red blood cell transfusions, white cell growth factors, folic acid, and iron supplementation, as needed. Effectiveness will be determined by the number of patients who receive an allogenic blood transfusion during the study and the change in hemoglobin at 3 or 4 weeks, 8 or 9 weeks, and 12 weeks, and at the end of the treatment period. Safety evaluations (incidence of adverse events, abnormal clinical laboratory tests, and vital signs) will be performed throughout the study. The study hypothesis is that cancer patients receiving chemotherapy who receive early treatment with epoetin alfa will have higher hemoglobin levels and fewer red blood cell transfusions than cancer patients receiving chemotherapy who receive standard treatment with epoetin alfa. This study will be conducted in the Netherlands and will only enroll European patients and will be generally well-tolerated. Epoetin alfa injections (40,000 units) under skin once a week either within 7 days after start of first chemotherapy cycle or from day hemoglobin is <=10 g/dL. Patients will receive epoetin alfa during the current course of chemotherapy or up to 24 weeks. Dose may be adjusted.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Confirmed diagnosis of cancer and planned to receive chemotherapy in 1, 2, 3, or 4 weekly schedules for a minimum of 8 weeks
- have a hemoglobin level of >10 grams per deciliter and <= 12 grams per deciliter within 14 days before the start of the first on-study chemotherapy cycle
- Eastern Cooperative Oncology Group (scale used by researchers to represent the level of activity a patient is capable of) score of 0 (able to carry out all normal activity without restriction) to 2 (ambulatory and capable of all self-care but unable to carry out any work)
- life expectancy of >=6 months
- female subjects postmenopausal for at least 1 year, surgically sterile or practicing an effective method of birth control
Key exclusion criteria (8 listed)
- Clinically significant or uncontrolled disease/dysfunction of any body system that is not due to cancer or chemotherapy, including uncontrolled or severe cardiovascular disease, recent (< 6 months) myocardial infarction, uncontrolled high blood pressure, congestive heart failure, or uncontrolled or unexplained history of seizures
- planned surgery expected to influence hemoglobin levels, within the first 8 or 9 weeks of study entry
- major illness or infection within 1 month of study entry
- highly increased risk of thrombotic or other vascular events
- androgen therapy within 2 months of study entry
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 hemoglobin from the start of the study to 3 or 4, 8 or 9, and 12 weeks, and at the end of the treatment period
1 secondary outcome
Number of patients who receive an allogenic blood transfusion during the study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2011.
- Results publication: PubMed 18343652Schouwink JH, Codrington H, Sleeboom HP, Kerkhofs LG, Wormhoudt LW. Prevention of anaemia by early intervention with once weekly epoetin alfa during chemotherapy. Eur J Cancer. 2008 Apr;44(6):819-29. doi: 10.1016/j.ejca.2008.02.017. Epub 2008 Mar 17.
- Treatment with Recombinant Epoetin Alfa Started Upfront: A Randomised study with Eprex (TREASURE)Link provided by the sponsor.
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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.
Janssen-Cilag B.V. Clinical Trial study director
Janssen-Cilag B.V.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing epoetin alfa in people with Anemia and Neoplasms, run by Janssen-Cilag B.V..
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 5 inclusion and 8 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: finished, as of the sponsor's last update on 19 May 2011. Status can change between updates, so confirm with the study contact before making plans.
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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 hemoglobin from the start of the study to 3 or 4, 8 or 9, and 12 weeks, and at the end of the treatment period. 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 NCT00216541, 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 19 May 2011.