AnemiaPhase 4NCT00315484
Hematologic Response of Epoetin Alfa (PROCRIT) Versus Darbepoetin Alfa (ARANESP) in Chemotherapy Induced Anemia
A Phase 4 study testing Epoetin alfa and Darbepoetin alfa in people with Anemia and Chemotherapy, run by Ortho Biotech Products, L.P..
Trial summary
The purpose of this study is to compare hemoglobin (Hgb) response rates between epoetin alfa (PROCRIT; 40,000 Units (U) SC weekly) and darbepoetin alfa (ARANESP; 200 mcg every other week) in anemic cancer patients receiving chemotherapy. 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 and Darbepoetin alfa
- How many people
- 358 participants
- Where
- No sites listed yet
- Study dates
- Feb 2003to Oct 2004
- 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
- Histologically confirmed diagnosis of a solid tumor malignancy
- Baseline hemoglobin value of <11 g/dL
- Scheduled to receive cyclic chemotherapy for a minimum of 12 weeks
- < 2 prior chemotherapy regimens in a metastatic setting
- Adequate hematologic \& renal function and platelet count >100,000/mm3
- Estimated life expectancy of > 6 months
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0 - 2
Who cannot join
- History of stem cell or bone marrow transplant
- Anemia due to factors other than cancer/chemotherapy
- Prior treatment with epoetin alfa or darbepoetin alfa or any investigational forms of erythropoietin within the previous 3 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 recent history (within 6 months) of uncontrolled cardiac arrhythmias, pulmonary embolism, thrombosis
- new onset of seizures
Show all 9Show fewer
- history of second active malignancy
- Major infection requiring hospitalization and antibiotics within 14 days of randomization
- Transfusion of white blood cells or packed red blood cells within 28 days of randomization.
About this study
Official title: A Randomized, Open-Label Study Of Epoetin Alfa (PROCRIT) Versus Darbepoetin Alfa (ARANESP) To Evaluate Hematologic Response Rate In Anemic Cancer Patients Receiving Chemotherapy
The purpose of this study is to compare hemoglobin (Hgb) response rates between epoetin alfa (PROCRIT; 40,000 Units (U) SC weekly) and darbepoetin alfa (ARANESP; 200 mcg every other week) in anemic cancer patients receiving chemotherapy.
Read the detailed description
Chemotherapy related anemia occurs in a majority of cancer patients and can cause impaired treatment outcomes, increased treatment-related complications and altered quality of life. Epoetin alfa administered on a weekly dosing schedule of 40,000 Units subcutaneously ([SC], under the skin) with dose adjustments based on hematologic response produces significant improvement in hemoglobin levels, decreased transfusion frequency and improved quality of life. It is unknown if the recently developed agent, darbepoetin alfa, administered on an every other week fixed dose will produce similar improvements in hematologic and quality of life outcomes. Thus, further randomization studies are warranted utilizing once weekly dosing (QW) of Epoetin alfa compared to once every other week (Q2W) darbepoetin alfa. Patients will receive study medications for up to 16 weeks.Safety \& efficacy evaluations will be performed at specified intervals throughout the study.The study hypothesis is that the Week 5 hemoglobin response rate in the Epoetin alfa group is better than that in the Darbepoetin alfa group. The starting dose for study drug is either Epoetin alfa (PROCRIT) 40,000 Units SC QW or Darbepoetin alfa (ARANESP) 200 mcg SC Q2W. Doses may be adjusted depending on the patient's hemoglobin levels up a maximum of 60,000 IU SC QW Epoetin alfa or 300 mcg SC Q2W Darbepoetin alfa.
- Conditions
- Anemia, Chemotherapy
- Being tested
- Epoetin alfa and Darbepoetin alfa
- Keywords
- Anemia, chemotherapy, hemoglobin level, recombinant human erythropoietin, epoetin alfa, darbepoetin 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 alfa and Darbepoetin alfaDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary efficacy endpoint will evaluate the proportion of patients achieving >1 g/dL hemoglobin increase by week 5.
Secondary outcomes (1)
1) time to hemoglobin (Hgb) increase of 1g/dL; 2) proportion of pts achieving a >1 g/dL Hgb increase by Wk 9; 3) proportion of pts achieving a >2g/dL Hgb increase by Wk 9; 4) Hgb values over time; 5) cumulative RBC transfusion Wk 5 to end of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2006 (estimated)
- Study startFeb 2003
- Study completionOct 2004
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 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 358 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ortho Biotech Products, L.P.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Ortho Biotech Products, L.P. Clinical Trial, Study director, Ortho Biotech Products, L.P.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00315484
- Sponsor's protocol ID
- CR004609
- Status last verified
- Apr 2010
- First submitted
- 14 Apr 2006
- Last updated
- 19 May 2011
- Results posted
- No
Publications
Waltzman R, Croot C, Justice GR, Fesen MR, Charu V, Williams D. Randomized comparison of epoetin alfa (40,000 U weekly) and darbepoetin alfa (200 microg every 2 weeks) in anemic patients with cancer receiving chemotherapy. Oncologist. 2005 Sep;10(8):642-50. doi: 10.1634/theoncologist.10-8-642.
PubMed 16177289
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-Label Study Of Epoetin Alfa (PROCRIT) Versus Darbepoetin Alfa (ARANESP) To Evaluate Hematologic Response Rate In Anemic Cancer Patients Receiving Chemotherapy
- ClinicalTrials.gov ID
- NCT00315484
- Acronym / sponsor ID
- CR004609
- Conditions
- Anemia, Chemotherapy
- Keywords
- Anemia, chemotherapy, hemoglobin level, recombinant human erythropoietin, epoetin alfa, darbepoetin alfa
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 358 participants (actual)
- Lead sponsor
- Ortho Biotech Products, L.P.Industry (pharma, biotech, devices)
- Study start
- Feb 2003
- Study completion
- Oct 2004 (actual)
- First posted
- 18 Apr 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 compare hemoglobin (Hgb) response rates between epoetin alfa (PROCRIT; 40,000 Units (U) SC weekly) and darbepoetin alfa (ARANESP; 200 mcg every other week) in anemic cancer patients receiving chemotherapy.
Detailed description
Chemotherapy related anemia occurs in a majority of cancer patients and can cause impaired treatment outcomes, increased treatment-related complications and altered quality of life. Epoetin alfa administered on a weekly dosing schedule of 40,000 Units subcutaneously ([SC], under the skin) with dose adjustments based on hematologic response produces significant improvement in hemoglobin levels, decreased transfusion frequency and improved quality of life. It is unknown if the recently developed agent, darbepoetin alfa, administered on an every other week fixed dose will produce similar improvements in hematologic and quality of life outcomes. Thus, further randomization studies are warranted utilizing once weekly dosing (QW) of Epoetin alfa compared to once every other week (Q2W) darbepoetin alfa. Patients will receive study medications for up to 16 weeks.Safety \& efficacy evaluations will be performed at specified intervals throughout the study.The study hypothesis is that the Week 5 hemoglobin response rate in the Epoetin alfa group is better than that in the Darbepoetin alfa group. The starting dose for study drug is either Epoetin alfa (PROCRIT) 40,000 Units SC QW or Darbepoetin alfa (ARANESP) 200 mcg SC Q2W. Doses may be adjusted depending on the patient's hemoglobin levels up a maximum of 60,000 IU SC QW Epoetin alfa or 300 mcg SC Q2W Darbepoetin alfa.
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 (7 listed)
- Histologically confirmed diagnosis of a solid tumor malignancy
- Baseline hemoglobin value of <11 g/dL
- Scheduled to receive cyclic chemotherapy for a minimum of 12 weeks
- < 2 prior chemotherapy regimens in a metastatic setting
- Adequate hematologic \& renal function and platelet count >100,000/mm3
Key exclusion criteria (9 listed)
- History of stem cell or bone marrow transplant
- Anemia due to factors other than cancer/chemotherapy
- Prior treatment with epoetin alfa or darbepoetin alfa or any investigational forms of erythropoietin within the previous 3 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 recent history (within 6 months) of uncontrolled cardiac arrhythmias, pulmonary embolism, thrombosis
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 and Darbepoetin alfa | Drug | – |
Primary outcome
The primary efficacy endpoint will evaluate the proportion of patients achieving >1 g/dL hemoglobin increase by week 5.
1 secondary outcome
1) time to hemoglobin (Hgb) increase of 1g/dL; 2) proportion of pts achieving a >1 g/dL Hgb increase by Wk 9; 3) proportion of pts achieving a >2g/dL Hgb increase by Wk 9; 4) Hgb values over time; 5) cumulative RBC transfusion Wk 5 to end of study
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 19 May 2011.
- Results publication: PubMed 16177289Waltzman R, Croot C, Justice GR, Fesen MR, Charu V, Williams D. Randomized comparison of epoetin alfa (40,000 U weekly) and darbepoetin alfa (200 microg every 2 weeks) in anemic patients with cancer receiving chemotherapy. Oncologist. 2005 Sep;10(8):642-50. doi: 10.1634/theoncologist.10-8-642.
- A Randomized, Open-Label Study of Epoetin Alfa (PROCRIT) Versus Darbepoetin Alfa (ARANESP) to Evaluate Hematologic Response Rate in Anemic Cancer Patients Receiving ChemotherapyLink 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 Products, L.P.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Epoetin alfa and Darbepoetin alfa in people with Anemia and Chemotherapy, 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 7 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: finished, as of the sponsor's last update on 19 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 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 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 efficacy endpoint will evaluate the proportion of patients achieving >1 g/dL hemoglobin increase by week 5.. 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 NCT00315484, 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 19 May 2011.