AnemiaPhase 2NCT00306267
A Study of PROCRIT (Epoetin Alfa) 80,000 Units (U) Once Every Four Weeks (Q4W) vs. 40,000 U Once Every Two Weeks (Q2W) in Cancer Patients Not Receiving Chemotherapy
A Phase 2 study testing epoetin alfa in people with Anemia and Cancer, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..
Trial summary
The purpose of this study is to assess the safety and effectiveness of PROCRIT (Epoetin alfa) administered by injection subcutaneously (SC, under the skin), at a dose of 80,000 U once every four weeks or 40,000 U once every two in anemic patients with cancer not receiving chemotherapy or radiation therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anemia, Cancer, Epoetin Alfa
- What is being tested?
- epoetin alfa
- How many people
- 61 participants
- Where
- No sites listed yet
- Study dates
- Mar 2006to May 2007
- Phase
- Phase 2
- 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 must have "Active non-myeloid cancer malignancy" or incurable cancer with a life expectancy of 6 months or more
- Patients may also have had cancer treatment within the past 2 years but no chemotherapy or radiation therapy within the past 8 weeks prior to enrollment
- must be >= 18 years of age and must not be receiving or planning to receive cytotoxic chemotherapy or external beam radiotherapy during the study period
- must have a baseline Hb <= 11 g/dL.
- Patients with reproductive potential must be practicing an effective method of birth control and women cannot be pregnant or breast-feeding during the study period
- Patients must be able to comply with all requirements of the study (i.e. study visit schedules) and patients (or their legally authorized representatives) must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study
Who cannot join
- Patients receiving or planning to receive chemotherapy or radiation therapy within 8 weeks of study entry
- Anemia due to factors other than cancer
- Previous treatment with epoetin alfa or any form of erythropoietin during the previous 1 month or received an experimental drug or device within past 30 days
- Known hypersensitivity to mammalian-cell derived products or to human albumin
- Untreated known central nervous system (CNS) metastases
- Uncontrolled or clinically severe disease of the pulmonary, cardiovascular, endocrine, neurologic, gastrointestinal, or genitourinary systems not attributable to underlying malignancy or chemotherapy
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- History of (within 12 months) deep venous thrombosis (DVT), pulmonary embolus (PE), or other venous thrombotic events, cerebrovascular accident (CVA), transient ischemic attack (TIA), Acute Coronary Syndrome (ACS) [unstable angina, myocardial infarction (MI)], or other arterial thrombosis
- Currently receiving therapeutic or prophylactic anticoagulants
- Transfusion of packed red blood cells within 28 days prior to the first dose of study drug, or planned stem cell harvest of bone marrow or high dose chemotherapy with stem cell transplant during study duration.
About this study
Official title: A Pilot Study to Evaluate the Safety and Efficacy of PROCRIT (Epoetin Alfa) 80,000 Units Once Every Four Weeks (Q4W) vs. 40,000 Units Once Every Two Weeks (Q2W) in Cancer Subjects With Non-Chemotherapy Anemia (NCA)
The purpose of this study is to assess the safety and effectiveness of PROCRIT (Epoetin alfa) administered by injection subcutaneously (SC, under the skin), at a dose of 80,000 U once every four weeks or 40,000 U once every two in anemic patients with cancer not receiving chemotherapy or radiation therapy.
Read the detailed description
Epoetin alfa is an analogue (has the identical amino acid sequence) of erythropoetin, a hormone secreted by kidneys known to stimulate red blood cell production. Although epoetin alfa has been known to be effective in treatment of anemia associated with cancer chemotherapy, there are no specific formal guidelines on the use of epoetin alfa for the treatment of anemia in cancer patients not receiving chemotherapy or radiation therapy. Several prospective clinical trials investigating the efficacy of epoetin alfa in cancer-associated anemia included groups of patients not receiving chemotherapy where it was demonstrated that the use of epoetin alfa in this population was safe and effective in increasing hemoglobin (Hb) levels and reducing transfusion requirements. The optimal dosing regimen of epoetin alfa in cancer patients not receiving chemotherapy or radiation therapy remains unclear.
This 17-week study is a prospective, randomized, open-label, multi-center study to assess the safety and effectiveness of epoetin alfa in anemic patients with cancer not receiving chemotherapy or radiation therapy. Eligible patients with hemoglobin level <= 11 g/dL will receive epoetin alfa 40,000 U once every 2 weeks for 15 weeks or 80,000 U once every 4 weeks for 13 weeks. The study hypothesis are that there are no long-term safety concerns of epoetin alfa administered at these two dosing regimens and that both dosing regimens are equally effective in this patient population. Eligible patients with hemoglobin levels <= 11 g/dL will receive epoetin alfa 40,000 U once every 2 weeks for 15 weeks or 80,000 U once every 4 weeks for 13 weeks.
- Conditions
- Anemia, Cancer, Epoetin Alfa
- Being tested
- epoetin alfa
- Keywords
- Anemia, non-chemotherapy-induced, non-radiation therapy-induced, cancer, non-myeloid
- 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.
The primary efficacy endpoint will be hematopoietic response, defined as >= 1 g/dL rise in hemoglobin from baseline.
Secondary outcomes (1)
Secondary objectives are to assess the two dosing regimens on time-to-hematopoietic response and transfusion requirements. Safety assessments will include laboratory tests, blood pressure, physical examination and severity of adverse events.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2006 (estimated)
- Study startMar 2006
- Study completionMay 2007
Why it stopped: Study stopped as it would not address important survival concerns raised in other recently conducted clinical studies.
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Ortho Biotech Products, L.P.
- 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
- NCT00306267
- Sponsor's protocol ID
- CR010540
- Status last verified
- Mar 2010
- First submitted
- 21 Mar 2006
- Last updated
- 18 May 2011
- Results posted
- No
- Data monitoring committee
- 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 Pilot Study to Evaluate the Safety and Efficacy of PROCRIT (Epoetin Alfa) 80,000 Units Once Every Four Weeks (Q4W) vs. 40,000 Units Once Every Two Weeks (Q2W) in Cancer Subjects With Non-Chemotherapy Anemia (NCA)
- ClinicalTrials.gov ID
- NCT00306267
- Acronym / sponsor ID
- CR010540
- Conditions
- Anemia, Cancer, Epoetin Alfa
- Keywords
- Anemia, non-chemotherapy-induced, non-radiation therapy-induced, cancer, non-myeloid
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study stopped as it would not address important survival concerns raised in other recently conducted clinical studies.
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.Industry (pharma, biotech, devices)
- Collaborators
- Ortho Biotech Products, L.P.
- Study start
- Mar 2006
- Study completion
- May 2007 (actual)
- First posted
- 23 Mar 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 assess the safety and effectiveness of PROCRIT (Epoetin alfa) administered by injection subcutaneously (SC, under the skin), at a dose of 80,000 U once every four weeks or 40,000 U once every two in anemic patients with cancer not receiving chemotherapy or radiation therapy.
Detailed description
Epoetin alfa is an analogue (has the identical amino acid sequence) of erythropoetin, a hormone secreted by kidneys known to stimulate red blood cell production. Although epoetin alfa has been known to be effective in treatment of anemia associated with cancer chemotherapy, there are no specific formal guidelines on the use of epoetin alfa for the treatment of anemia in cancer patients not receiving chemotherapy or radiation therapy. Several prospective clinical trials investigating the efficacy of epoetin alfa in cancer-associated anemia included groups of patients not receiving chemotherapy where it was demonstrated that the use of epoetin alfa in this population was safe and effective in increasing hemoglobin (Hb) levels and reducing transfusion requirements. The optimal dosing regimen of epoetin alfa in cancer patients not receiving chemotherapy or radiation therapy remains unclear.
This 17-week study is a prospective, randomized, open-label, multi-center study to assess the safety and effectiveness of epoetin alfa in anemic patients with cancer not receiving chemotherapy or radiation therapy. Eligible patients with hemoglobin level <= 11 g/dL will receive epoetin alfa 40,000 U once every 2 weeks for 15 weeks or 80,000 U once every 4 weeks for 13 weeks. The study hypothesis are that there are no long-term safety concerns of epoetin alfa administered at these two dosing regimens and that both dosing regimens are equally effective in this patient population. Eligible patients with hemoglobin levels <= 11 g/dL will receive epoetin alfa 40,000 U once every 2 weeks for 15 weeks or 80,000 U once every 4 weeks for 13 weeks.
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 (6 listed)
- Patients must have "Active non-myeloid cancer malignancy" or incurable cancer with a life expectancy of 6 months or more
- Patients may also have had cancer treatment within the past 2 years but no chemotherapy or radiation therapy within the past 8 weeks prior to enrollment
- must be >= 18 years of age and must not be receiving or planning to receive cytotoxic chemotherapy or external beam radiotherapy during the study period
- must have a baseline Hb <= 11 g/dL.
- Patients with reproductive potential must be practicing an effective method of birth control and women cannot be pregnant or breast-feeding during the study period
Key exclusion criteria (9 listed)
- Patients receiving or planning to receive chemotherapy or radiation therapy within 8 weeks of study entry
- Anemia due to factors other than cancer
- Previous treatment with epoetin alfa or any form of erythropoietin during the previous 1 month or received an experimental drug or device within past 30 days
- Known hypersensitivity to mammalian-cell derived products or to human albumin
- Untreated known central nervous system (CNS) metastases
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
The primary efficacy endpoint will be hematopoietic response, defined as >= 1 g/dL rise in hemoglobin from baseline.
1 secondary outcome
Secondary objectives are to assess the two dosing regimens on time-to-hematopoietic response and transfusion requirements. Safety assessments will include laboratory tests, blood pressure, physical examination and severity of adverse events.
Results and safety
The study was stopped early (reason given: Study stopped as it would not address important survival concerns raised in other recently conducted clinical studies.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2011.
- A Pilot Study to Evaluate the Safety and Efficacy of PROCRIT� (epoetin alfa) 80,000 Units Once Every 4 Weeks (q4w) vs. 40,000 Units Once Every 2 Weeks (q2w) in Cancer Subjects With Non-Chemotherapy Anemia (NCA)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.
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 2 study testing epoetin alfa in people with Anemia and Cancer, 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 6 inclusion and 9 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 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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: Study stopped as it would not address important survival concerns raised in other recently conducted clinical studies.). 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?
The primary efficacy endpoint will be hematopoietic response, defined as >= 1 g/dL rise in hemoglobin from baseline.. 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.