ChemotherapyPhase 4NCT00495378
RAPID-2. A Study to Evaluate the Effectiveness of Alternate Dosing of PROCRIT (Epoetin Alfa) in Maintaining Hemoglobin Levels in Patients With Chemotherapy Related Anemia
A Phase 4 study testing epoetin alfa in people with Chemotherapy and Cancer, run by Ortho Biotech Products, L.P..
Trial summary
The purpose of this study was to determine if alternate dosing of Epoetin alfa was effective in maintaining hemoglobin levels in patients with chemotherapy related anemia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chemotherapy, Cancer, Anemia
- What is being tested?
- epoetin alfa
- How many people
- 25 participants
- Where
- No sites listed yet
- Study dates
- Nov 2002to Mar 2003
- 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 with chemotherapy related anemia
- Patients with a diagnosis of malignancy
- Patients with initial weekly PROCRIT (Epoetin alfa) therapy for at least 4 weeks
- Patients must have received PROCRIT (Epoetin alfa) maintenance therapy with less frequent dosing (e.g. every 2 weeks, every 3 weeks, every 4 weeks) for at least 6 weeks immediately following once weekly dosing.
Who cannot join
- No previous diagnosis of hemolytic anemia or myelodysplasia
About this study
Official title: Retrospective Review of Alternate PROCRIT Dosing In Patients With Chemotherapy Related Anemia
The purpose of this study was to determine if alternate dosing of Epoetin alfa was effective in maintaining hemoglobin levels in patients with chemotherapy related anemia.
Read the detailed description
This was a retrospective chart review of patients with chemotherapy related anemia. Two hundred (200) patients with chemotherapy related anemia were to have received PROCRIT (Epoetin alfa) on a weekly schedule (e.g., once every week or more frequently) for at least 4 weeks, followed by a maintenance PROCRIT (Epoetin alfa) schedule of less frequent dosing (e.g. once every 2 weeks, once every 3 weeks, or once every 4 weeks) for at least 6 weeks. Hemoglobin response and maintenance of initial treatment phase hemoglobin with alternate doses of PROCRIT (Epoetin alfa) were to be evaluated.Study sites were to record data in a Case Report Form which would then be entered into a database. Data was to be recorded, starting with the PROCRIT (Epoetin alfa) initiation phase (at least 4 weeks duration), and extending through at least 6 weeks of maintenance therapy. A minimum of 20 study sites were to be enrolled in the data collection process.Data obtained was to be analyzed to reflect alternate dosing patterns of PROCRIT (Epoetin alfa) therapy. The frequency and percentage of patients receiving each dosing regimen were to be summarized. Hemoglobin response and maintenance of initial treatment phase hemoglobin with alternate doses of PROCRIT (Epoetin alfa) were to be evaluated. If PROCRIT (Epoetin alfa) was discontinued, the time and reason(s) for discontinuation were to be recorded.
Patients were to have received PROCRIT (Epoetin alfa) subcutaneous injection on a weekly schedule (e.g., once every week or more frequently) for at least 4 weeks, followed by a maintenance PROCRIT (Epoetin alfa) schedule of less frequent dosing (e.g. once every 2 weeks, 3 weeks, or 4 weeks) for at least 6 weeks.
- Conditions
- Chemotherapy, Cancer, Anemia
- Being tested
- epoetin alfa
- Keywords
- PROCRIT, Epoetin alfa, chemotherapy related anemia
- 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.
Frequency and percentage of subjects in each dosing regimen will be summarized. Hemoglobin (Hb) response and maintenance of initial treatment phase Hb with alternate doses of Epoetin alfa. Time and reasons for discontinuing Epoetin alfa.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2007 (estimated)
- Study startNov 2002
- Study completionMar 2003
Why it stopped: This study was stopped due to slow enrollment after enrolling 25 of 200 patients.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ChemotherapyStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ortho Biotech Products, L.P.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ortho Biotech Products, L.P. Clinical Trial, Study director, Ortho Biotech, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00495378
- Sponsor's protocol ID
- CR005128
- Status last verified
- Jun 2007
- First submitted
- 29 Jun 2007
- Last updated
- 20 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Review of Alternate PROCRIT Dosing In Patients With Chemotherapy Related Anemia
- ClinicalTrials.gov ID
- NCT00495378
- Acronym / sponsor ID
- CR005128
- Conditions
- Chemotherapy, Cancer, Anemia
- Keywords
- PROCRIT, Epoetin alfa, chemotherapy related anemia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: This study was stopped due to slow enrollment after enrolling 25 of 200 patients.
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Ortho Biotech Products, L.P.Industry (pharma, biotech, devices)
- Study start
- Nov 2002
- Study completion
- Mar 2003 (actual)
- First posted
- 3 Jul 2007 (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 was to determine if alternate dosing of Epoetin alfa was effective in maintaining hemoglobin levels in patients with chemotherapy related anemia.
Detailed description
This was a retrospective chart review of patients with chemotherapy related anemia. Two hundred (200) patients with chemotherapy related anemia were to have received PROCRIT (Epoetin alfa) on a weekly schedule (e.g., once every week or more frequently) for at least 4 weeks, followed by a maintenance PROCRIT (Epoetin alfa) schedule of less frequent dosing (e.g. once every 2 weeks, once every 3 weeks, or once every 4 weeks) for at least 6 weeks. Hemoglobin response and maintenance of initial treatment phase hemoglobin with alternate doses of PROCRIT (Epoetin alfa) were to be evaluated.Study sites were to record data in a Case Report Form which would then be entered into a database. Data was to be recorded, starting with the PROCRIT (Epoetin alfa) initiation phase (at least 4 weeks duration), and extending through at least 6 weeks of maintenance therapy. A minimum of 20 study sites were to be enrolled in the data collection process.Data obtained was to be analyzed to reflect alternate dosing patterns of PROCRIT (Epoetin alfa) therapy. The frequency and percentage of patients receiving each dosing regimen were to be summarized. Hemoglobin response and maintenance of initial treatment phase hemoglobin with alternate doses of PROCRIT (Epoetin alfa) were to be evaluated. If PROCRIT (Epoetin alfa) was discontinued, the time and reason(s) for discontinuation were to be recorded.
Patients were to have received PROCRIT (Epoetin alfa) subcutaneous injection on a weekly schedule (e.g., once every week or more frequently) for at least 4 weeks, followed by a maintenance PROCRIT (Epoetin alfa) schedule of less frequent dosing (e.g. once every 2 weeks, 3 weeks, or 4 weeks) for at least 6 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- 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 with chemotherapy related anemia
- Patients with a diagnosis of malignancy
- Patients with initial weekly PROCRIT (Epoetin alfa) therapy for at least 4 weeks
- Patients must have received PROCRIT (Epoetin alfa) maintenance therapy with less frequent dosing (e.g. every 2 weeks, every 3 weeks, every 4 weeks) for at least 6 weeks immediately following once weekly dosing.
Key exclusion criteria (1 listed)
- No previous diagnosis of hemolytic anemia or myelodysplasia
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
Frequency and percentage of subjects in each dosing regimen will be summarized. Hemoglobin (Hb) response and maintenance of initial treatment phase Hb with alternate doses of Epoetin alfa. Time and reasons for discontinuing Epoetin alfa.
Results and safety
The study was stopped early (reason given: This study was stopped due to slow enrollment after enrolling 25 of 200 patients.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2016.
- For FDA Approved Product labeling, refer to the following link:http://www.accessdata.fda.gov/scripts/cder/drugsatfda/Link provided by the sponsor.
- Additional information is provided at the following link:http://dailymed.nlm.nih.gov/dailymed/about.cfmLink 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.
Ortho Biotech Products, L.P. Clinical Trial study director
Ortho Biotech, Inc.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing epoetin alfa in people with Chemotherapy and Cancer, run by Ortho Biotech Products, L.P..
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 1 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 20 Dec 2016. 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 was stopped early (reason given: This study was stopped due to slow enrollment after enrolling 25 of 200 patients.). 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?
Frequency and percentage of subjects in each dosing regimen will be summarized. Hemoglobin (Hb) response and maintenance of initial treatment phase Hb with alternate doses of Epoetin alfa. Time and reasons for discontinuing Epoetin alfa.. 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 20 Dec 2016.