AnemiaPhase 2NCT00338299
Alternate Dosing of PROCRIT (Epoetin Alfa) in Patients With Cancer and Chemotherapy Induced Anemia
A Phase 2 study testing Epoetin alfa in people with Anemia and Chemotherapy, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..
Trial summary
The purpose of this study was to test the effectiveness and safety of PROCRIT (Epoetin alfa) at a higher starting dose (60,000 Units) once per week, followed by a less frequent dose (60,000 Units every two weeks) in patients with cancer and chemotherapy induced anemia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anemia, Chemotherapy
- What is being tested?
- Epoetin alfa
- How many people
- 51 participants
- Where
- No sites listed yet
- Study dates
- Aug 2003to Apr 2004
- 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
- Histologically confirmed diagnosis of non-myeloid malignancy (no history of myelodysplasia allowed) with a baseline hemoglobin of <= 11 g/dL, planned to receive chemotherapy for a minimum of 12 weeks
- Life expectancy of >= 6 months with an Eastern Cooperative Oncology Group (ECOG) Performance Status 0 - 2
- Negative serum pregnancy test at Screening and adequate contraceptive during treatment and for three months after treatment
- Adequate hematologic function, adequate renal function and adequate hepatic function.
Who cannot join
- Planned radiation during the study
- Anemia due to factors other than cancer/chemotherapy (i.e., iron, B12 or folate deficiencies, hemolysis or gastrointestinal bleeding)
- Prior treatment with Epoetin alfa or any other erythropoietic agent (e.g., Darbepoetin alfa) within the previous three months
- Significant, uncontrolled disease/dysfunction of the pulmonary, cardiovascular, endocrine, neurologic, gastrointestinal, or genitourinary systems not attributable to underlying malignancy or chemotherapy, uncontrolled hypertension or history of uncontrolled cardiac arrhythmias, pulmonary embolism, thrombosis
- Transfusion of platelets or packed red blood cells within 28 days prior to the first dose of study medication
- Planned stem cell harvest of bone marrow or high dose chemotherapy with stem cell transplant during study duration.
About this study
Official title: An Open-Label Pilot Study to Evaluate the Effects of Alternate Dosing of PROCRIT� (Epoetin Alfa) in the Treatment of Patients With Cancer and Chemotherapy Induced Anemia (60,000 Units Weekly for Four Weeks Followed by 60,000 Units Every Two Weeks)
The purpose of this study was to test the effectiveness and safety of PROCRIT (Epoetin alfa) at a higher starting dose (60,000 Units) once per week, followed by a less frequent dose (60,000 Units every two weeks) in patients with cancer and chemotherapy induced anemia.
Read the detailed description
This was an open-label, non-randomized, multicenter pilot study where patients who were receiving chemotherapy for non-myeloid malignancy (cancer) with a baseline hemoglobin (Hb) <= 11 g/dL were enrolled. The primary objective of this pilot study was to estimate the hematologic responses for the dosing regimen of PROCRIT (Epoetin alfa), starting at a dose of 60,000 Units (U) administered subcutaneously (sc, under the skin) once per week (qw) for four weeks ("Phase A"), followed by a dose of 60,000 U every two weeks (q2w) ("Phase B") in patients with cancer and chemotherapy induced anemia. If, at any time during the study the Hb level rose to >13 g/dL, PROCRIT (Epoetin alfa) therapy was held until the Hb reached <=12 g/dL, then resumed at a reduced dose in both Phase A and Phase B. The dose was also reduced if a very rapid Hb response occurred (i.e. an increase of more than 1.3 g/dL in a 2-week period). The secondary objective of the study was to determine the incidence of anti-erythropoietin antibodies (anti-EPO Ab), at baseline and at end of study/early withdrawal in patients who had received a minimum of one dose of PROCRIT (Epoetin alfa). Rarely, anti-erythropoietin antibodies may form in patients who have some types of diseases (e.g., autoimmune diseases, rheumatoid arthritis, anemia of chronic disease), or in response to exposure to erythropoietin products such as Epoetin alfa necessitating discontinuation of the erythropoietin agent and medical treatment that may include blood transfusions.
Safety evaluations included clinical laboratory tests (hemoglobin and hematocrit), vital signs measurements (blood pressure), and incidence and severity of adverse events.
This study determined if higher initial weekly doses resulted in a higher initial response rate and/or a more brisk hemoglobin rise. Patients received PROCRIT (Epoetin alfa) 60,000 Units (U) once a week for 4 weeks. At Week 5 if hemoglobin increased by >= 1 g/dL above baseline, the PROCRIT dose was changed to 60,000 U every 2 weeks for <= 12 weeks. An additional PROCRIT dose was given if chemotherapy completed before Week 16.
- Conditions
- Anemia, Chemotherapy
- Being tested
- Epoetin alfa
- Keywords
- Anemia, hemoglobin, chemotherapy, subcutaneous injection, Epoetin alfa
- Medical subject headings
- 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 with a >= 1 g/dL increase in Hb above baseline in Phase A independent of transfusion within 4 weeks
Secondary outcomes (1)
Phase B: Maintain or increase the absolute Hb level achieved in Phase A (up to 0.9 g/dL higher) or maintain or increase the Hb level above that achieved in Phase A independent of transfusion within 4 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 startAug 2003
- Study completionApr 2004
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
- 51 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
- NCT00338299
- Sponsor's protocol ID
- CR005098
- Status last verified
- Apr 2010
- First submitted
- 16 Jun 2006
- Last updated
- 23 May 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Pilot Study to Evaluate the Effects of Alternate Dosing of PROCRIT� (Epoetin Alfa) in the Treatment of Patients With Cancer and Chemotherapy Induced Anemia (60,000 Units Weekly for Four Weeks Followed by 60,000 Units Every Two Weeks)
- ClinicalTrials.gov ID
- NCT00338299
- Acronym / sponsor ID
- CR005098
- Conditions
- Anemia, Chemotherapy
- Keywords
- Anemia, hemoglobin, chemotherapy, subcutaneous injection, Epoetin alfa
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.Industry (pharma, biotech, devices)
- Collaborators
- Ortho Biotech Products, L.P.
- Study start
- Aug 2003
- Study completion
- Apr 2004 (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 was to test the effectiveness and safety of PROCRIT (Epoetin alfa) at a higher starting dose (60,000 Units) once per week, followed by a less frequent dose (60,000 Units every two weeks) in patients with cancer and chemotherapy induced anemia.
Detailed description
This was an open-label, non-randomized, multicenter pilot study where patients who were receiving chemotherapy for non-myeloid malignancy (cancer) with a baseline hemoglobin (Hb) <= 11 g/dL were enrolled. The primary objective of this pilot study was to estimate the hematologic responses for the dosing regimen of PROCRIT (Epoetin alfa), starting at a dose of 60,000 Units (U) administered subcutaneously (sc, under the skin) once per week (qw) for four weeks ("Phase A"), followed by a dose of 60,000 U every two weeks (q2w) ("Phase B") in patients with cancer and chemotherapy induced anemia. If, at any time during the study the Hb level rose to >13 g/dL, PROCRIT (Epoetin alfa) therapy was held until the Hb reached <=12 g/dL, then resumed at a reduced dose in both Phase A and Phase B. The dose was also reduced if a very rapid Hb response occurred (i.e. an increase of more than 1.3 g/dL in a 2-week period). The secondary objective of the study was to determine the incidence of anti-erythropoietin antibodies (anti-EPO Ab), at baseline and at end of study/early withdrawal in patients who had received a minimum of one dose of PROCRIT (Epoetin alfa). Rarely, anti-erythropoietin antibodies may form in patients who have some types of diseases (e.g., autoimmune diseases, rheumatoid arthritis, anemia of chronic disease), or in response to exposure to erythropoietin products such as Epoetin alfa necessitating discontinuation of the erythropoietin agent and medical treatment that may include blood transfusions.
Safety evaluations included clinical laboratory tests (hemoglobin and hematocrit), vital signs measurements (blood pressure), and incidence and severity of adverse events.
This study determined if higher initial weekly doses resulted in a higher initial response rate and/or a more brisk hemoglobin rise. Patients received PROCRIT (Epoetin alfa) 60,000 Units (U) once a week for 4 weeks. At Week 5 if hemoglobin increased by >= 1 g/dL above baseline, the PROCRIT dose was changed to 60,000 U every 2 weeks for <= 12 weeks. An additional PROCRIT dose was given if chemotherapy completed before Week 16.
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)
- Histologically confirmed diagnosis of non-myeloid malignancy (no history of myelodysplasia allowed) with a baseline hemoglobin of <= 11 g/dL, planned to receive chemotherapy for a minimum of 12 weeks
- Life expectancy of >= 6 months with an Eastern Cooperative Oncology Group (ECOG) Performance Status 0 - 2
- Negative serum pregnancy test at Screening and adequate contraceptive during treatment and for three months after treatment
- Adequate hematologic function, adequate renal function and adequate hepatic function.
Key exclusion criteria (6 listed)
- Planned radiation during the study
- Anemia due to factors other than cancer/chemotherapy (i.e., iron, B12 or folate deficiencies, hemolysis or gastrointestinal bleeding)
- Prior treatment with Epoetin alfa or any other erythropoietic agent (e.g., Darbepoetin alfa) within the previous three months
- Significant, uncontrolled disease/dysfunction of the pulmonary, cardiovascular, endocrine, neurologic, gastrointestinal, or genitourinary systems not attributable to underlying malignancy or chemotherapy, uncontrolled hypertension or history of uncontrolled cardiac arrhythmias, pulmonary embolism, thrombosis
- Transfusion of platelets or packed red blood cells within 28 days prior to the first dose of study medication
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 with a >= 1 g/dL increase in Hb above baseline in Phase A independent of transfusion within 4 weeks
1 secondary outcome
Phase B: Maintain or increase the absolute Hb level achieved in Phase A (up to 0.9 g/dL higher) or maintain or increase the Hb level above that achieved in Phase A independent of transfusion within 4 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 23 May 2011.
- An Open-Label Pilot Study to Evaluate the Effects of Alternate Dosing of PROCRIT� (Epoetin Alfa) in the Treatment of Patients with Cancer and Chemotherapy Induced Anemia (60,000 Units Weekly for Four Weeks Followed by 60,000 Units Every Two Weeks)Link provided by the sponsor.
- \|Reddy PK; Williams D; Wilhelm FE. An Open-Label Pilot to Evaluate a Flexible Dosing Regimen of Epoetin Alfa for the Treatment of Chemotherapy-Induced Anemia: 60,000 Units Weekly Followed by 60,000 Units Every 2 WeeksLink 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 Chemotherapy, 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 6 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 23 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?
Proportion of patients with a >= 1 g/dL increase in Hb above baseline in Phase A independent of transfusion within 4 weeks. 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 23 May 2011.