AnemiaPhase 4NCT00283465
A Study of the Effectiveness and Safety of Treatment With Epoetin Alfa on Hemoglobin Levels, Red Blood Cell Transfusions, and Quality of Life in Patients With Cancer Receiving Platinum-containing Chemotherapy
A Phase 4 study testing Epoetin alfa in people with Anemia and Neoplasm, run by Janssen-Cilag B.V..
Trial summary
The purpose of this study is to compare the effectiveness of early treatment of anemia with epoetin alfa (a glycoprotein that stimulates red blood cell production) or best standard anemia care on the need for blood transfusions, tumor response, anemia and quality of life in patients with cancer receiving… Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Epoetin alfa
- How many people
- 316 participants
- Where
- No sites listed yet
- Study dates
- Nov 1999to Apr 2004
- 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
- Patients having a confirmed diagnosis of cancer and are planned to receive platinum chemotherapy with a minimum of 8 weeks on study and a maximum of 6 or 12 cycles
- Eastern Cooperative Oncology Group (a scale used by researchers to represent the level of activity that a patient is capable of) score of 0 (able to carry out all normal activity without restriction) to 3 (capable of only limited self-care, confined to bed or chair >50% of waking hours)
- life expectancy of >=5 months
- have a hemoglobin value of <=7.5 grams per deciliter at any time during or prior to chemotherapy
Who cannot join
- Patients having clinically significant disease/dysfunction of the pulmonary, cardiovascular, endocrine, neurological, gastrointestinal, or genitourinary systems that is not due to cancer or chemotherapy (this disease/dysfunction is only an exclusion criterion if it causes an expected early withdrawal from the study)
- uncontrolled high blood pressure
- history of seizures
- untreated iron, folate, or vitamin B12 deficiency
- received androgen (e.g., testosterone) therapy within 2 months of study entry, had a major illness within 7 days of study entry, or a major infection within 1 month of study entry
About this study
Official title: An Open-label, Randomized Study to Evaluate the Effect of Early Treatment of Anemia With Epoetin Alfa on Hemoglobin, the Incidence of Blood Transfusions and Quality of Life in Patients Receiving Platinum-containing Chemotherapy
The purpose of this study is to compare the effectiveness of early treatment of anemia with epoetin alfa (a glycoprotein that stimulates red blood cell production) or best standard anemia care on the need for blood transfusions, tumor response, anemia and quality of life in patients with cancer receiving platinum-containing chemotherapy.
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 epoetin alfa increases hemoglobin and reduces the incidence of red blood cell transfusions and that achieving a higher hemoglobin level may improve quality of life. This is a randomized, open-label, multicenter study that evaluates the effects of early treatment with epoetin alfa compared with standard anemia care alone to determine its impact on the need for blood transfusions, tumor response, anemia and quality of life, as well as on the safety of epoetin alfa when used in the prevention of anemia during chemotherapy in adult patients with cancer. Patients will receive epoetin alfa injections (10,000 units) under the skin 3 times a week until 4 weeks after the last day of the last chemotherapy cycle, in addition to best standard care, or best standard care alone. Best standard care during chemotherapy may include red blood cell transfusions, white cell growth factors, and iron supplementation, as needed. The dose of epoetin alfa may be adjusted up (to 20,000 units) or down (to 75% of the last dose) based on hemoglobin level.
The primary measure of effectiveness will be determined by the number of patients who receive an allogenic red blood cell transfusion during the study and during each chemotherapy cycle. Additional measures of effectiveness include: the average number of units transfused during each cycle, change in quality of life (feeling of well-being, as assessed by responses to 3 different patient questionnaires), change in hemoglobin level, relationship between change in hemoglobin and quality of life, tumor response, and the number of patients surviving up to 12 months after the end of treatment. Safety evaluations (incidence of adverse events, clinical laboratory tests, vital signs, and physical examinations) will be performed throughout the study. The study hypothesis is that treatment with epoetin alfa will reduce the need for red blood cell transfusions, increase hemoglobin levels, improve quality of life, and result in a positive tumor response in patients with cancer who are receiving chemotherapy. This study will be conducted in the Netherlands and will only enroll European patients. Patients will receive epoetin alfa injections (10,000 units) under the skin 3 times a week until 4 weeks after the last day of the last chemotherapy cycle, or best standard care. Dose may be adjusted up (to 20,000 units) or down (to 75% of the last dose) based on hemoglobin level.
- Being tested
- Epoetin alfa
- Keywords
- Anemia, cancer, neoplasm, transfusion, quality of life, tumor response, survival, 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.
Number of patients who receive an allogenic red blood cell transfusion during the study, during each chemotherapy cycle, and at 4 weeks after the last administration of chemotherapy
Secondary outcomes (1)
Number of units transfused during each chemotherapy cycle; change in quality of life; change in hemoglobin level; relationship between change in hemoglobin and quality of life; tumor response; patient survival up to 12 months after the end of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2006 (estimated)
- Study startNov 1999
- Study completionApr 2004
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
- 316 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
- NCT00283465
- Sponsor's protocol ID
- CR002047
- Status last verified
- Jan 2011
- First submitted
- 27 Jan 2006
- Last updated
- 14 Jan 2011
- Results posted
- No
Publications
Savonije JH, van Groeningen CJ, van Bochove A, Honkoop AH, van Felius CL, Wormhoudt LW, Giaccone G. Effects of early intervention with epoetin alfa on transfusion requirement, hemoglobin level and survival during platinum-based chemotherapy: Results of a multicenter randomised controlled trial. Eur J Cancer. 2005 Jul;41(11):1560-9. doi: 10.1016/j.ejca.2005.03.024.
PubMed 15953714
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Randomized Study to Evaluate the Effect of Early Treatment of Anemia With Epoetin Alfa on Hemoglobin, the Incidence of Blood Transfusions and Quality of Life in Patients Receiving Platinum-containing Chemotherapy
- ClinicalTrials.gov ID
- NCT00283465
- Acronym / sponsor ID
- CR002047
- Keywords
- Anemia, cancer, neoplasm, transfusion, quality of life, tumor response, survival, chemotherapy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 316 participants (actual)
- Lead sponsor
- Janssen-Cilag B.V.Industry (pharma, biotech, devices)
- Study start
- Nov 1999
- Study completion
- Apr 2004 (actual)
- First posted
- 30 Jan 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 purpose of this study is to compare the effectiveness of early treatment of anemia with epoetin alfa (a glycoprotein that stimulates red blood cell production) or best standard anemia care on the need for blood transfusions, tumor response, anemia and quality of life in patients with cancer receiving platinum-containing chemotherapy.
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 epoetin alfa increases hemoglobin and reduces the incidence of red blood cell transfusions and that achieving a higher hemoglobin level may improve quality of life. This is a randomized, open-label, multicenter study that evaluates the effects of early treatment with epoetin alfa compared with standard anemia care alone to determine its impact on the need for blood transfusions, tumor response, anemia and quality of life, as well as on the safety of epoetin alfa when used in the prevention of anemia during chemotherapy in adult patients with cancer. Patients will receive epoetin alfa injections (10,000 units) under the skin 3 times a week until 4 weeks after the last day of the last chemotherapy cycle, in addition to best standard care, or best standard care alone. Best standard care during chemotherapy may include red blood cell transfusions, white cell growth factors, and iron supplementation, as needed. The dose of epoetin alfa may be adjusted up (to 20,000 units) or down (to 75% of the last dose) based on hemoglobin level.
The primary measure of effectiveness will be determined by the number of patients who receive an allogenic red blood cell transfusion during the study and during each chemotherapy cycle. Additional measures of effectiveness include: the average number of units transfused during each cycle, change in quality of life (feeling of well-being, as assessed by responses to 3 different patient questionnaires), change in hemoglobin level, relationship between change in hemoglobin and quality of life, tumor response, and the number of patients surviving up to 12 months after the end of treatment. Safety evaluations (incidence of adverse events, clinical laboratory tests, vital signs, and physical examinations) will be performed throughout the study. The study hypothesis is that treatment with epoetin alfa will reduce the need for red blood cell transfusions, increase hemoglobin levels, improve quality of life, and result in a positive tumor response in patients with cancer who are receiving chemotherapy. This study will be conducted in the Netherlands and will only enroll European patients. Patients will receive epoetin alfa injections (10,000 units) under the skin 3 times a week until 4 weeks after the last day of the last chemotherapy cycle, or best standard care. Dose may be adjusted up (to 20,000 units) or down (to 75% of the last dose) based on hemoglobin level.
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 (4 listed)
- Patients having a confirmed diagnosis of cancer and are planned to receive platinum chemotherapy with a minimum of 8 weeks on study and a maximum of 6 or 12 cycles
- Eastern Cooperative Oncology Group (a scale used by researchers to represent the level of activity that a patient is capable of) score of 0 (able to carry out all normal activity without restriction) to 3 (capable of only limited self-care, confined to bed or chair >50% of waking hours)
- life expectancy of >=5 months
- have a hemoglobin value of <=7.5 grams per deciliter at any time during or prior to chemotherapy
Key exclusion criteria (5 listed)
- Patients having clinically significant disease/dysfunction of the pulmonary, cardiovascular, endocrine, neurological, gastrointestinal, or genitourinary systems that is not due to cancer or chemotherapy (this disease/dysfunction is only an exclusion criterion if it causes an expected early withdrawal from the study)
- uncontrolled high blood pressure
- history of seizures
- untreated iron, folate, or vitamin B12 deficiency
- received androgen (e.g., testosterone) therapy within 2 months of study entry, had a major illness within 7 days of study entry, or a major infection within 1 month 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
Number of patients who receive an allogenic red blood cell transfusion during the study, during each chemotherapy cycle, and at 4 weeks after the last administration of chemotherapy
1 secondary outcome
Number of units transfused during each chemotherapy cycle; change in quality of life; change in hemoglobin level; relationship between change in hemoglobin and quality of life; tumor response; patient survival up to 12 months after the end of treatment
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 14 Jan 2011.
- Results publication: PubMed 15953714Savonije JH, van Groeningen CJ, van Bochove A, Honkoop AH, van Felius CL, Wormhoudt LW, Giaccone G. Effects of early intervention with epoetin alfa on transfusion requirement, hemoglobin level and survival during platinum-based chemotherapy: Results of a multicenter randomised controlled trial. Eur J Cancer. 2005 Jul;41(11):1560-9. doi: 10.1016/j.ejca.2005.03.024.
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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 Neoplasm, 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 4 inclusion and 5 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 14 Jan 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?
Number of patients who receive an allogenic red blood cell transfusion during the study, during each chemotherapy cycle, and at 4 weeks after the last administration of chemotherapy. 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 NCT00283465, 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 14 Jan 2011.