AnemiaPhase 2NCT00388336
PROCRIT (Epoetin Alfa) 60,000 Units Administered Once Every Two Weeks in Anemic Cancer Patients Who Are Not Receiving Chemotherapy or Radiation Therapy
A Phase 2 study testing Epoetin Alfa in people with Anemia and Neoplasms, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..
Trial summary
The purpose of this study is to evaluate the effectiveness and safety of Epoetin alfa administered at 60,000 Units every two weeks in cancer patients who are not receiving chemotherapy or radiation therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Epoetin Alfa
- How many people
- 57 participants
- Where
- No sites listed yet
- Study dates
- Feb 2004to Mar 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must have histologically confirmed diagnosis of non-myeloid malignancy
- Baseline hemoglobin value of <= 11 g/dL unrelated to transfusion
- Patients must not be receiving or planning to receive chemotherapy or radiotherapy within the 16-week study period. However, patients receiving hormonal therapy or non-myelosuppressive therapies are allowable
- Female patients with reproductive potential must have a negative serum pregnancy test at screening.
Who cannot join
- Patients must not have uncontrolled hypertension or a history (within 6 months) of uncontrolled cardiac arrhythmias, pulmonary emboli, deep vein thrombosis, ischemic stroke, other arterial or venous thrombotic events (excluding superficial thromboses), or known history of chronic coagulation disorder
- No transfusion within 28 days prior to first dose
- No planned chemotherapy or radiation during study and no prior chemotherapy within 8 weeks or radiation within 4 weeks of study entry
- No prior treatment with Epoetin alfa or any other erythropoietic agent within the previous two months.
About this study
Official title: A Pilot Study to Evaluate the Response Rate of PROCRIT� (Epoetin Alfa) at 60,000 Units Every Two Weeks in Anemic Cancer Patients Not Receiving Chemotherapy Or Radiation Therapy
The purpose of this study is to evaluate the effectiveness and safety of Epoetin alfa administered at 60,000 Units every two weeks in cancer patients who are not receiving chemotherapy or radiation therapy.
Read the detailed description
This was an open-label (doctors and patients knew which drug was being administered), non-randomized (patients were assigned to treatment), multi-center pilot study with the objective to investigate the effectiveness of PROCRIT (Epoetin alfa) on hematopoietic response (effect on red blood cells) when administered at 60,000 Units subcutaneously (under the skin) every two weeks in anemic patients with cancer who were not receiving chemotherapy or radiation therapy.
Treatment with study drug was for a maximum of 12 weeks followed by a 4-week observation period after the last dose of the study drug had been administered.
Safety and efficacy evaluations were performed at specified intervals throughout the study and included assessment of laboratory tests (Complete Blood Count [CBC], Serum Chemistry [including hemoglobin level]), vital signs (such as blood pressure), physical examinations and the occurrence and severity of adverse events. All patients enrolled in this study received pharmacologic ferrous sulfate 325 mg by mouth once a day or an equivalent formulation, as tolerated, unless it was determined by the physician that the patient should not receive it. All patient's received injections of PROCRIT (Epoetin alfa) 60,000 Units under the skin once every two weeks. If after 4 weeks of treatment, the patient's hemoglobin level did not increase by >= 1 g/dL, the Epoetin alfa dose was increased to 80,000 Units every 2 weeks. Study drug was administered for a maximum of 12 weeks followed by a 4-week observation period after the last dose of study drug. Epoetin alfa doses were reduced or held as needed depending on the patients' hemoglobin level.
- Being tested
- Epoetin Alfa
- Keywords
- Anemia, Neoplasms, Hemoglobin values, PROCRIT, Epoetin alfa
- 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 endpoint was to evaluate hematopoietic response, defined as >= 2 g/dL Hb increase from baseline and/or Hb >= 12 g/dL over the course of the study and independent of transfusion within 28 days.
Secondary outcomes (1)
Secondary endpoints included the effects of PROCRIT (Epoetin alfa) on transfusion requirements, on Quality of Life as measured by the Linear Analog Scale Assessment (LASA) and FACT-An tools as well as time to hemoglobin response.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2006 (estimated)
- Study startFeb 2004
- Study completionMar 2005
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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Ortho Biotech Clinical Affairs, L.L.C.
- 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
- NCT00388336
- Sponsor's protocol ID
- CR004594
- Status last verified
- Apr 2010
- First submitted
- 13 Oct 2006
- 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 Pilot Study to Evaluate the Response Rate of PROCRIT� (Epoetin Alfa) at 60,000 Units Every Two Weeks in Anemic Cancer Patients Not Receiving Chemotherapy Or Radiation Therapy
- ClinicalTrials.gov ID
- NCT00388336
- Acronym / sponsor ID
- CR004594
- Keywords
- Anemia, Neoplasms, Hemoglobin values, PROCRIT, Epoetin alfa
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.Industry (pharma, biotech, devices)
- Collaborators
- Ortho Biotech Clinical Affairs, L.L.C.
- Study start
- Feb 2004
- Study completion
- Mar 2005 (actual)
- First posted
- 16 Oct 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 evaluate the effectiveness and safety of Epoetin alfa administered at 60,000 Units every two weeks in cancer patients who are not receiving chemotherapy or radiation therapy.
Detailed description
This was an open-label (doctors and patients knew which drug was being administered), non-randomized (patients were assigned to treatment), multi-center pilot study with the objective to investigate the effectiveness of PROCRIT (Epoetin alfa) on hematopoietic response (effect on red blood cells) when administered at 60,000 Units subcutaneously (under the skin) every two weeks in anemic patients with cancer who were not receiving chemotherapy or radiation therapy.
Treatment with study drug was for a maximum of 12 weeks followed by a 4-week observation period after the last dose of the study drug had been administered.
Safety and efficacy evaluations were performed at specified intervals throughout the study and included assessment of laboratory tests (Complete Blood Count [CBC], Serum Chemistry [including hemoglobin level]), vital signs (such as blood pressure), physical examinations and the occurrence and severity of adverse events. All patients enrolled in this study received pharmacologic ferrous sulfate 325 mg by mouth once a day or an equivalent formulation, as tolerated, unless it was determined by the physician that the patient should not receive it. All patient's received injections of PROCRIT (Epoetin alfa) 60,000 Units under the skin once every two weeks. If after 4 weeks of treatment, the patient's hemoglobin level did not increase by >= 1 g/dL, the Epoetin alfa dose was increased to 80,000 Units every 2 weeks. Study drug was administered for a maximum of 12 weeks followed by a 4-week observation period after the last dose of study drug. Epoetin alfa doses were reduced or held as needed depending on the patients' hemoglobin level.
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 must have histologically confirmed diagnosis of non-myeloid malignancy
- Baseline hemoglobin value of <= 11 g/dL unrelated to transfusion
- Patients must not be receiving or planning to receive chemotherapy or radiotherapy within the 16-week study period. However, patients receiving hormonal therapy or non-myelosuppressive therapies are allowable
- Female patients with reproductive potential must have a negative serum pregnancy test at screening.
Key exclusion criteria (4 listed)
- Patients must not have uncontrolled hypertension or a history (within 6 months) of uncontrolled cardiac arrhythmias, pulmonary emboli, deep vein thrombosis, ischemic stroke, other arterial or venous thrombotic events (excluding superficial thromboses), or known history of chronic coagulation disorder
- No transfusion within 28 days prior to first dose
- No planned chemotherapy or radiation during study and no prior chemotherapy within 8 weeks or radiation within 4 weeks of study entry
- No prior treatment with Epoetin alfa or any other erythropoietic agent within the previous two 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
The primary endpoint was to evaluate hematopoietic response, defined as >= 2 g/dL Hb increase from baseline and/or Hb >= 12 g/dL over the course of the study and independent of transfusion within 28 days.
1 secondary outcome
Secondary endpoints included the effects of PROCRIT (Epoetin alfa) on transfusion requirements, on Quality of Life as measured by the Linear Analog Scale Assessment (LASA) and FACT-An tools as well as time to hemoglobin response.
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.
- A Pilot Study to Evaluate the Response Rate of PROCRIT (Epoetin Alfa) at 60,000 Units Every Two Weeks in Anemic Patients with Cancer Not Receiving Chemotherapy or Radiation TherapyLink 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 Neoplasms, 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 4 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 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?
The primary endpoint was to evaluate hematopoietic response, defined as >= 2 g/dL Hb increase from baseline and/or Hb >= 12 g/dL over the course of the study and independent of transfusion within 28 days.. 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.