CancerPhase 2NCT00338416
An Efficacy and Safety Study of PROCRIT (Epoetin Alfa) in Cancer Patients Receiving Chemotherapy Every Three Weeks
A Phase 2 study testing Epoetin alfa in people with Cancer and Anemia, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..
Trial summary
The purpose of this study is to determine the effectiveness and safety of PROCRIT (Epoetin alfa) at a starting dose of 60,000 Units (U) once every week (QW) to a target hemoglobin (Hb) of 12 g/dL (Initiation Phase), followed by a dose of 80,000 Units once every three weeks (Q3W) to maintain a Hb range of 11.5 to 12.5… Read more about this study
- Who is it for?
- Ages 19 years and older
- What is being tested?
- Epoetin alfa
- How many people
- 115 participants
- Where
- No sites listed yet
- Study dates
- Mar 2003to Jan 2005
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed diagnosis of non-myeloid malignancy and receiving chemotherapy
- Baseline Hb of <= 11 g/dL
- Planned chemotherapy for a minimum of 15 weeks to be administered every 3 weeks
- Female patients with reproductive potential must have a negative serum pregnancy test at screening.
Who cannot join
- No uncontrolled hypertension or recent history (within 6 months) of uncontrolled cardiac arrhythmias
- No pulmonary embolism
- or thrombosis
- No transfusion of white blood cells or packed red blood cells within 28 days of Epoetin alfa treatment
- No prior treatment with Epoetin alfa or any other erythropoetic agent within the previous three months
About this study
Official title: An Open-Labeled Pilot Study to Evaluate the Effects of High Dose PROCRIT (Epoetin Alfa) in Maintaining Hemoglobin Levels in Anemic Cancer Patients Receiving Chemotherapy on a Every Three Week Regimen
The purpose of this study is to determine the effectiveness and safety of PROCRIT (Epoetin alfa) at a starting dose of 60,000 Units (U) once every week (QW) to a target hemoglobin (Hb) of 12 g/dL (Initiation Phase), followed by a dose of 80,000 Units once every three weeks (Q3W) to maintain a Hb range of 11.5 to 12.5 g/dL (Maintenance Phase) in cancer patients receiving chemotherapy.
Read the detailed description
Epoetin alfa administered three times weekly (150 U/kg) or once weekly (40,000 U) results in a response rate (defined as >= 2 g/dL Hb increase or Hb >= 12 g/dL) of approximately 65% of anemic chemotherapy patients and produces a mean hemoglobin (Hg) rise of 1.8 g/dL. Higher weekly dosing of epoetin alfa may result in a higher response rate and a more timely mean hemoglobin rise while remaining safe. Additionally, limited data are available to show whether epoetin alfa maintenance therapy can be administered less frequently than weekly and still maintain hemoglobin levels. This is an open label, multicenter, non-randomized study to determine the safety and effectiveness of epoetin alfa given to cancer patients receiving chemotherapy every three weeks.
Patients will receive injections of PROCRIT (Epoetin alfa) 60,000 Units (U) once weekly (QW) under the skin for up to 12 weeks (Initiation Phase) to achieve a hemoglobin (Hg) level of 12 g/dL until next full chemotherapy cycle. At that time they will begin the Maintenance Phase and will receive up to 4 injections of Epoetin alfa 80,000 U every 3 weeks (Q3W) under the skin for up to an additional 12 weeks. Doses will be held and adjusted downward if hemoglobin level rises to >13 g/dL or if a very rapid hemoglobin response occurs (e.g., an increase of more than 1.3 g/dL in a 2-week period).
Safety evaluations include clinical laboratory tests (hemoglobin and hematocrit), vital sign measurements (blood pressure), and adverse events. In addition, the antibodies that have developed against erythropoietin will be evaluated in patients who receive multiple doses of PROCRIT (Epoetin alfa). Patients will receive injections of Epoetin alfa 60,000 Units (U) once weekly (QW) under the skin for up to 12 weeks (Initiation Phase) to achieve a hemoglobin (Hg) level of 12 g/dL until next full chemotherapy cycle. At that time they will begin the Maintenance Phase and will receive up to 4 injections of Epoetin alfa 80,000 U every 3 weeks (Q3W) under the skin for up to an additional 12 weeks.
- Being tested
- Epoetin alfa
- Keywords
- Chemotherapy Induced Anemia, PROCRIT (Epoetin alfa), Chemotherapy, Epoetin alfa
- Medical subject headings
- 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.
Proportion of patients achieving >= 2 g/dL Hb increase from baseline or Hb >= 12 g/dL in the Initiation Phase (up to 12 weeks).
Secondary outcomes (1)
Proportion of patients with >=1 g/dL Hb increase from baseline (up to 1.9 g/dL) in the Initiation Phase; those maintaining Hb level >11 g/dL (up to 11.4 g/dL); and those maintaining Hb level 11.5 to 12.5 g/dL in the Maintenance Phase (up to 12 weeks).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2006 (estimated)
- Study startMar 2003
- Study completionJan 2005
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 CancerStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 115 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
- NCT00338416
- Sponsor's protocol ID
- CR004612
- Status last verified
- Apr 2010
- First submitted
- 16 Jun 2006
- Last updated
- 10 Jun 2011
- Results posted
- No
Publications
Montoya VP, Xie J, Williams D, Woodman RC, Wilhelm FE. An extended maintenance dosing regimen of epoetin alfa 80,000 U every 3 weeks in anemic patients with cancer receiving chemotherapy. Support Care Cancer. 2007 Dec;15(12):1385-92. doi: 10.1007/s00520-007-0263-6. Epub 2007 May 31.
PubMed 17541653
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Labeled Pilot Study to Evaluate the Effects of High Dose PROCRIT (Epoetin Alfa) in Maintaining Hemoglobin Levels in Anemic Cancer Patients Receiving Chemotherapy on a Every Three Week Regimen
- ClinicalTrials.gov ID
- NCT00338416
- Acronym / sponsor ID
- CR004612
- Keywords
- Chemotherapy Induced Anemia, PROCRIT (Epoetin alfa), Chemotherapy, Epoetin alfa
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 115 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 2003
- Study completion
- Jan 2005 (actual)
- First posted
- 20 Jun 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 determine the effectiveness and safety of PROCRIT (Epoetin alfa) at a starting dose of 60,000 Units (U) once every week (QW) to a target hemoglobin (Hb) of 12 g/dL (Initiation Phase), followed by a dose of 80,000 Units once every three weeks (Q3W) to maintain a Hb range of 11.5 to 12.5 g/dL (Maintenance Phase) in cancer patients receiving chemotherapy.
Detailed description
Epoetin alfa administered three times weekly (150 U/kg) or once weekly (40,000 U) results in a response rate (defined as >= 2 g/dL Hb increase or Hb >= 12 g/dL) of approximately 65% of anemic chemotherapy patients and produces a mean hemoglobin (Hg) rise of 1.8 g/dL. Higher weekly dosing of epoetin alfa may result in a higher response rate and a more timely mean hemoglobin rise while remaining safe. Additionally, limited data are available to show whether epoetin alfa maintenance therapy can be administered less frequently than weekly and still maintain hemoglobin levels. This is an open label, multicenter, non-randomized study to determine the safety and effectiveness of epoetin alfa given to cancer patients receiving chemotherapy every three weeks.
Patients will receive injections of PROCRIT (Epoetin alfa) 60,000 Units (U) once weekly (QW) under the skin for up to 12 weeks (Initiation Phase) to achieve a hemoglobin (Hg) level of 12 g/dL until next full chemotherapy cycle. At that time they will begin the Maintenance Phase and will receive up to 4 injections of Epoetin alfa 80,000 U every 3 weeks (Q3W) under the skin for up to an additional 12 weeks. Doses will be held and adjusted downward if hemoglobin level rises to >13 g/dL or if a very rapid hemoglobin response occurs (e.g., an increase of more than 1.3 g/dL in a 2-week period).
Safety evaluations include clinical laboratory tests (hemoglobin and hematocrit), vital sign measurements (blood pressure), and adverse events. In addition, the antibodies that have developed against erythropoietin will be evaluated in patients who receive multiple doses of PROCRIT (Epoetin alfa). Patients will receive injections of Epoetin alfa 60,000 Units (U) once weekly (QW) under the skin for up to 12 weeks (Initiation Phase) to achieve a hemoglobin (Hg) level of 12 g/dL until next full chemotherapy cycle. At that time they will begin the Maintenance Phase and will receive up to 4 injections of Epoetin alfa 80,000 U every 3 weeks (Q3W) under the skin for up to an additional 12 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Histologically confirmed diagnosis of non-myeloid malignancy and receiving chemotherapy
- Baseline Hb of <= 11 g/dL
- Planned chemotherapy for a minimum of 15 weeks to be administered every 3 weeks
- Female patients with reproductive potential must have a negative serum pregnancy test at screening.
Key exclusion criteria (5 listed)
- No uncontrolled hypertension or recent history (within 6 months) of uncontrolled cardiac arrhythmias
- No pulmonary embolism
- or thrombosis
- No transfusion of white blood cells or packed red blood cells within 28 days of Epoetin alfa treatment
- No prior treatment with Epoetin alfa or any other erythropoetic agent within the previous three months
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 achieving >= 2 g/dL Hb increase from baseline or Hb >= 12 g/dL in the Initiation Phase (up to 12 weeks).
1 secondary outcome
Proportion of patients with >=1 g/dL Hb increase from baseline (up to 1.9 g/dL) in the Initiation Phase; those maintaining Hb level >11 g/dL (up to 11.4 g/dL); and those maintaining Hb level 11.5 to 12.5 g/dL in the Maintenance Phase (up to 12 weeks).
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 10 Jun 2011.
- Results publication: PubMed 17541653Montoya VP, Xie J, Williams D, Woodman RC, Wilhelm FE. An extended maintenance dosing regimen of epoetin alfa 80,000 U every 3 weeks in anemic patients with cancer receiving chemotherapy. Support Care Cancer. 2007 Dec;15(12):1385-92. doi: 10.1007/s00520-007-0263-6. Epub 2007 May 31.
- An Open-label Pilot Study to Evaluate the Effects of High Dose PROCRIT (Epoetin alfa) in Maintaining Hemoglobin Levels in Anemic Cancer Patients Receiving Chemotherapy on an Every 3 Week RegimenLink 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 Cancer and Anemia, 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 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 10 Jun 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 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 achieving >= 2 g/dL Hb increase from baseline or Hb >= 12 g/dL in the Initiation Phase (up to 12 weeks).. 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 NCT00338416, 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 10 Jun 2011.