AnemiaPhase 3NCT00270166
The Effect of Epoetin Alfa on the Anemia of Patients With Selected Cancers Receiving Chemotherapy
A Phase 3 study testing epoetin alfa in people with Anemia and Multiple Myeloma, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..
Trial summary
The purpose of this study is to evaluate the safety and effectiveness of epoetin alfa versus placebo in reducing or preventing the need for transfusions in anemic patients with cancer receiving chemotherapy, and to investigate possible quality-of-life benefits associated with the use of epoetin alfa. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Anemia, Multiple Myeloma, Lymphoma
- What is being tested?
- epoetin alfa
- How many people
- 201 participants
- Where
- No sites listed yet
- Study dates
- Feb 1995to May 1998
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Confirmed diagnosis of multiple myeloma, lymphoma, breast cancer, ovarian cancer, small-cell lung cancer, esophagus cancer, or prostate cancer
- receiving treatment with chemotherapy, with at least 3 additional months of chemotherapy planned
- a self-care performance score of 0 (fully active, no disease restriction) to 3 (capable of only limited self-care, confined to bed or chair more than 50% of waking hours)
- life expectancy of at least 6 months
- baseline hemoglobin <12 grams per deciliter and baseline count of <100,000 microliter for developing red cells
Who cannot join
- Clinically significant disease other than cancer
- evidence of uncontrolled hypertension or history of seizure
- transfusion within 1 week of the study
- radiotherapy within 2 weeks of study start
- use of corticosteroid or steroid drugs during the study.
About this study
Official title: A Placebo-Controlled Study on the Effect of Epoetin Alfa in Patients With Malignancy Receiving Chemotherapy
The purpose of this study is to evaluate the safety and effectiveness of epoetin alfa versus placebo in reducing or preventing the need for transfusions in anemic patients with cancer receiving chemotherapy, and to investigate possible quality-of-life benefits associated with the use of epoetin alfa. Epoetin alfa is a genetically engineered protein that stimulates red blood cell production.
Read the detailed description
Cancer patients often experience anemia due to the disease itself, chemotherapy, or both. Quality of life is also affected, in part because of the fatigue associated with anemia. Previous studies with epoetin alfa have suggested that achieving a higher hemoglobin level may improve quality of life and help patients live longer. This study is a 12-week, double-blind, placebo-controlled multicenter study to compare the ability of epoetin alfa and placebo in reducing or preventing anemia and transfusions, and to investigate quality-of-life benefits associated with the use of epoetin alfa in patients receiving chemotherapy for selected cancers. During the double-blind period there will be two groups of patients: one group receiving epoetin injections under the skin 3 times per week (starting at 150 units per kilogram, adjusted if needed to a maximum of 300 units per kilogram) and other group receiving injections under the skin of a placebo of matching appearance and volume. If hemoglobin rises above 140 grams per liter (women) or 150 grams per liter (men), the dose will be adjusted to keep hemoglobin within a target range. A 12-week open-label extension of the study will be available to all patients completing the 12-week comparison period. The primary measure of effectiveness is determined by the proportion of patients with no transfusions after the first month. Additional measures of effectiveness include: the proportion of responders, the change of hemoglobin unrelated to transfusion, cumulative transfusion rate and proportion of patients transfused during the double-blind phase (excluding the first month), as well as the mean change over the study period in scores for energy, activity and overall quality of life. The results will be analyzed separately for non-platinum-containing chemotherapy and for different tumor types. Safety evaluations include assessments of the incidence and severity of adverse events, clinical laboratory tests, vital sign measurements, and physical examinations. The hypothesis of the study is that epoetin alfa is superior to placebo in improving anemia, reducing the number of transfusions, and improving quality of life. Epoetin alfa 150 units (U) per kilogram (kg) or placebo, injected under the skin 3 times weekly for 4 weeks; then either continued at 150 U/kg or adjusted to 300 U/kg according to hemoglobin levels for the remaining 8 weeks. Open-label (12 weeks): dose to maintain target hemoglobin range.
- Conditions
- Anemia, Multiple Myeloma, Lymphoma, Breast Cancer, Ovarian Cancer, Carcinoma, Small Cell Lung
- Being tested
- epoetin alfa
- Keywords
- cancer, malignancy, red cell transfusion, epoetin alfa, epoetin, erythropoietin, red blood cells
- Medical subject headings
- Anemia, Multiple Myeloma, Lymphoma, Breast Neoplasms, Ovarian Neoplasms, Small Cell Lung Carcinoma, Esophageal Neoplasms, Prostatic 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.
Proportion of patients without transfusion after first month.
Secondary outcomes (1)
Proportion of responders, change of hemoglobin (not by transfusion), cumulative transfusion rate, proportion of patients transfused during the double-blind phase, excluding the first month; mean change score of baseline quality of life parameters; safety
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2005 (estimated)
- Study startFeb 1995
- Study completionMay 1998
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 201 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial, Study director, Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00270166
- Sponsor's protocol ID
- CR005923
- Status last verified
- Feb 2011
- First submitted
- 22 Dec 2005
- Last updated
- 18 May 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Placebo-Controlled Study on the Effect of Epoetin Alfa in Patients With Malignancy Receiving Chemotherapy
- ClinicalTrials.gov ID
- NCT00270166
- Acronym / sponsor ID
- CR005923
- Conditions
- Anemia, Multiple Myeloma, Lymphoma, Breast Cancer, Ovarian Cancer, Carcinoma, Small Cell Lung
- Keywords
- cancer, malignancy, red cell transfusion, epoetin alfa, epoetin, erythropoietin, red blood cells
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 201 participants (actual)
- Lead sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.Industry (pharma, biotech, devices)
- Study start
- Feb 1995
- Study completion
- May 1998 (actual)
- First posted
- 26 Dec 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 safety and effectiveness of epoetin alfa versus placebo in reducing or preventing the need for transfusions in anemic patients with cancer receiving chemotherapy, and to investigate possible quality-of-life benefits associated with the use of epoetin alfa. Epoetin alfa is a genetically engineered protein that stimulates red blood cell production.
Detailed description
Cancer patients often experience anemia due to the disease itself, chemotherapy, or both. Quality of life is also affected, in part because of the fatigue associated with anemia. Previous studies with epoetin alfa have suggested that achieving a higher hemoglobin level may improve quality of life and help patients live longer. This study is a 12-week, double-blind, placebo-controlled multicenter study to compare the ability of epoetin alfa and placebo in reducing or preventing anemia and transfusions, and to investigate quality-of-life benefits associated with the use of epoetin alfa in patients receiving chemotherapy for selected cancers. During the double-blind period there will be two groups of patients: one group receiving epoetin injections under the skin 3 times per week (starting at 150 units per kilogram, adjusted if needed to a maximum of 300 units per kilogram) and other group receiving injections under the skin of a placebo of matching appearance and volume. If hemoglobin rises above 140 grams per liter (women) or 150 grams per liter (men), the dose will be adjusted to keep hemoglobin within a target range. A 12-week open-label extension of the study will be available to all patients completing the 12-week comparison period. The primary measure of effectiveness is determined by the proportion of patients with no transfusions after the first month. Additional measures of effectiveness include: the proportion of responders, the change of hemoglobin unrelated to transfusion, cumulative transfusion rate and proportion of patients transfused during the double-blind phase (excluding the first month), as well as the mean change over the study period in scores for energy, activity and overall quality of life. The results will be analyzed separately for non-platinum-containing chemotherapy and for different tumor types. Safety evaluations include assessments of the incidence and severity of adverse events, clinical laboratory tests, vital sign measurements, and physical examinations. The hypothesis of the study is that epoetin alfa is superior to placebo in improving anemia, reducing the number of transfusions, and improving quality of life. Epoetin alfa 150 units (U) per kilogram (kg) or placebo, injected under the skin 3 times weekly for 4 weeks; then either continued at 150 U/kg or adjusted to 300 U/kg according to hemoglobin levels for the remaining 8 weeks. Open-label (12 weeks): dose to maintain target hemoglobin range.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Confirmed diagnosis of multiple myeloma, lymphoma, breast cancer, ovarian cancer, small-cell lung cancer, esophagus cancer, or prostate cancer
- receiving treatment with chemotherapy, with at least 3 additional months of chemotherapy planned
- a self-care performance score of 0 (fully active, no disease restriction) to 3 (capable of only limited self-care, confined to bed or chair more than 50% of waking hours)
- life expectancy of at least 6 months
- baseline hemoglobin <12 grams per deciliter and baseline count of <100,000 microliter for developing red cells
Key exclusion criteria (5 listed)
- Clinically significant disease other than cancer
- evidence of uncontrolled hypertension or history of seizure
- transfusion within 1 week of the study
- radiotherapy within 2 weeks of study start
- use of corticosteroid or steroid drugs during the study.
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
Proportion of patients without transfusion after first month.
1 secondary outcome
Proportion of responders, change of hemoglobin (not by transfusion), cumulative transfusion rate, proportion of patients transfused during the double-blind phase, excluding the first month; mean change score of baseline quality of life parameters; safety
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 18 May 2011.
- The effect of epoetin alfa on the anemia of patients with selected cancersLink 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.
Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial study director
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing epoetin alfa in people with Anemia and Multiple Myeloma, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..
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 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 18 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 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 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?
Proportion of patients without transfusion after first month.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 May 2011.