AnemiaNCT00258440
Epoetin Alfa in Treating Patients With Anemia Who Are Undergoing Chemotherapy for Cancer
A study testing Weekly procrit dosing and Interval Dosing in people with Anemia and Fatigue, run by OHSU Knight Cancer Institute at 1 site in United States.
Trial summary
RATIONALE: Epoetin alfa may cause the body to make more red blood cells. It is used to treat anemia caused by cancer and chemotherapy. It may also help relieve fatigue in patients with anemia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anemia, Fatigue, Unspecified Adult Solid Tumor, Protocol Specific
- What is being tested?
- Weekly procrit dosing and Interval Dosing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- May 2003to Sep 2008
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
None listed.
Who cannot join
- Patient has uncontrolled hypertension
- Patient has history of symptomatic cardiac disease
- Patient has serious intercurrent illness
- The patient is pregnant, has a positive serum HCG or is lactating Patient has known hypersensitivity to mammalian cell-derived products or human albumin.
- Patient has diagnosis of polycythemia vera, chronic myelogenous leukemia, myelodysplastic syndrome
- May not be due for transplant within 24 weeks
Show all 10Show fewer
- Anemia due to factors other than cancer.
- History of a thrombotic vascular event.
- History of seizures
- Patient has received a red blood cell growth factor (epoetin alfa or darbepoetin) within the last 60 days
Trial locations and contacts
1 site in 1 country.
United States1 site
OHSU Knight Cancer Institute
Portland, Oregon, 97239-3098
About this study
Official title: A Pilot Trial of Extended Interval Dosing of Epoetin Alfa (Procrit®) for the Treatment of Anemia in Oncology Patients
RATIONALE: Epoetin alfa may cause the body to make more red blood cells. It is used to treat anemia caused by cancer and chemotherapy. It may also help relieve fatigue in patients with anemia.
PURPOSE: This randomized clinical trial is studying how well epoetin alfa works in treating patients with anemia who are undergoing chemotherapy for cancer.
Read the detailed description
OBJECTIVES:
Primary
- Determine the efficacy, in terms of maintenance of target hemoglobin and hematocrit levels, of interval dosing with epoetin alfa in treating patients with anemia undergoing chemotherapy for nonhematologic cancer.
Secondary
- Determine the pharmacokinetics and pharmacodynamics of this drug in these patients.
- Correlate hemoglobin and hematocrit response with patient age (> 65 years vs < 65 years) in patients treated with this drug.
- Determine quality of life of patients treated with this drug.
- Determine the adverse effects of this drug in these patients.
- Determine the change over time of symptom and quality of life variables (e.g., fatigue) in patients treated with this drug.
OUTLINE: This is a partially randomized, pilot study. Patients are stratified according to age (< 65 years vs ≥ 65 years). Patients are assigned to 1 of 2 treatment groups based on participation in the pharmacokinetic (PK) portion of the study.
- Group 1 (PK study, initial therapy): Patients are randomized to 1 of 2 treatment arms.
- Arm I: Five patients receive epoetin alfa subcutaneously (SC) once weekly. Treatment continues for 24 weeks in the absence of unacceptable toxicity.
- Arm II: Five patients receive epoetin alfa SC once weekly until hematocrit is > 36% OR hemoglobin reaches a value of 12 g/dL. Patients then proceed to maintenance therapy.
Patients in both arms also undergo PK sampling periodically during study treatment.
- Group 2 (non-PK study, initial therapy): Fifteen patients receive epoetin alfa SC once weekly until hematocrit is > 36% OR hemoglobin reaches a value of 12 g/dL. Patients then proceed to maintenance therapy.
- Maintenance therapy: Patients receive epoetin alfa SC once every other week for up to 24 weeks of total treatment (including both initial therapy and maintenance therapy). Patients whose blood counts fall below the critical levels are placed on a weekly dosing schedule. Patients whose blood counts rise too high discontinue study drug until blood counts are reduced.
Quality of life (including fatigue) is assessed at baseline and then every 4 weeks for 28 weeks.
After completion of study therapy, patients are followed at 4 weeks.
PROJECTED ACCRUAL: A total of 25 patients will be accrued for this study.
- Being tested
- Weekly procrit dosing, Interval Dosing
- Keywords
- fatigue, anemia, unspecified adult solid tumor, protocol specific
- Medical subject headings
- Anemia, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Weekly procrit dosingDrug
The dose is standard of care, the investigational piece is the dosing schedule itself. Either weekly or Interval-dosing schedule subjects will get the study drug once every week until hematocrit is greater than 36% or Hemoglobin reaches a value of 12 g/dl, then they will get study drug once every other week.
Interval DosingDrug
The dosing of Procrit is standard of care, it is the schedule that is the investigational piece.
| Study group | Role | What they receive |
|---|---|---|
| Weekly Procrit (epoetin alfa) dosing | Active comparator | Weekly dosing schedule subjects will get the study drug once every week until the end of the study. Receives: Drug: Weekly procrit dosing |
| Interval Dosing (epoetin alfa) PK Group | Experimental | Interval-dosing schedule subjects will get the study drug once every week until hematocrit is greater than 36% or Hemoglobin reaches a value of 12 g/dl, then they will get study drug once every other week. Subjects who consented to pharmacokinetic testing Receives: Drug: Interval Dosing |
| Interval Dosing (epoetin alfa) Non PK Group | Experimental | Interval-dosing schedule subjects will get the study drug once every week until hematocrit is greater than 36% or Hemoglobin reaches a value of 12 g/dl, then they will get study drug once every other week. Subjects who did not consent to pharmacokinetic testing. Receives: Drug: Interval Dosing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Subjects That Maintained Target Hemoglobin Level (11-12 g/dL) Maintenance Weekly for 12 Weeks
Measured: 12 weeks
Secondary outcomes (3)
Pharmacokinetics (PK) and Pharmacodynamics Assays That Measure Concentration of Erythropoietin in Serum.
Measured: every other week
Quality of Life at Baseline and Weeks 4, 8, 16, 24, and 28
Measured: weeks 4,8,16,24 and 28
Number of Adverse Events (AEs) Experienced as Measure of Safety and Tolerability.
Measured: On study, averaging 3 to 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2005 (estimated)
- Study startMay 2003
- Primary completionSep 2008
- Study completionSep 2008
Why it stopped: Sponsor discontinued funding of the study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for AnemiaStudies of the same condition, open and under way.
- More trials run by OHSU Knight Cancer InstituteThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- OHSU Knight Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Ortho Biotech, Inc.
- Responsible party
- Principal investigator, Joseph Bubalo, OHSU Knight Cancer Institute
- Investigators
- Joseph Bubalo, PharmD, BCPS, BCOP, Principal investigator, OHSU Knight Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00258440
- Sponsor's protocol ID
- CDR0000445450
- Other IDs
- OHSU-ONC-03017-LP, OHSU-1616, OHSU-7754, ORTHO-ONC-03017-LP
- Status last verified
- May 2017
- First submitted
- 23 Nov 2005
- Last updated
- 9 May 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Trial of Extended Interval Dosing of Epoetin Alfa (Procrit®) for the Treatment of Anemia in Oncology Patients
- ClinicalTrials.gov ID
- NCT00258440
- Acronym / sponsor ID
- CDR0000445450
- Keywords
- fatigue, anemia, unspecified adult solid tumor, protocol specific
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor discontinued funding of the study
- Enrolment
- 7 participants (actual)
- Lead sponsor
- OHSU Knight Cancer InstituteUniversity, hospital or other
- Collaborators
- Ortho Biotech, Inc.
- Study start
- May 2003
- Primary completion
- Sep 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 24 Nov 2005 (estimated)
- Results
- Posted 26 May 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Epoetin alfa may cause the body to make more red blood cells. It is used to treat anemia caused by cancer and chemotherapy. It may also help relieve fatigue in patients with anemia.
PURPOSE: This randomized clinical trial is studying how well epoetin alfa works in treating patients with anemia who are undergoing chemotherapy for cancer.
Detailed description
OBJECTIVES:
Primary
- Determine the efficacy, in terms of maintenance of target hemoglobin and hematocrit levels, of interval dosing with epoetin alfa in treating patients with anemia undergoing chemotherapy for nonhematologic cancer.
Secondary
- Determine the pharmacokinetics and pharmacodynamics of this drug in these patients.
- Correlate hemoglobin and hematocrit response with patient age (> 65 years vs < 65 years) in patients treated with this drug.
- Determine quality of life of patients treated with this drug.
- Determine the adverse effects of this drug in these patients.
- Determine the change over time of symptom and quality of life variables (e.g., fatigue) in patients treated with this drug.
OUTLINE: This is a partially randomized, pilot study. Patients are stratified according to age (< 65 years vs ≥ 65 years). Patients are assigned to 1 of 2 treatment groups based on participation in the pharmacokinetic (PK) portion of the study.
- Group 1 (PK study, initial therapy): Patients are randomized to 1 of 2 treatment arms.
- Arm I: Five patients receive epoetin alfa subcutaneously (SC) once weekly. Treatment continues for 24 weeks in the absence of unacceptable toxicity.
- Arm II: Five patients receive epoetin alfa SC once weekly until hematocrit is > 36% OR hemoglobin reaches a value of 12 g/dL. Patients then proceed to maintenance therapy.
Patients in both arms also undergo PK sampling periodically during study treatment.
- Group 2 (non-PK study, initial therapy): Fifteen patients receive epoetin alfa SC once weekly until hematocrit is > 36% OR hemoglobin reaches a value of 12 g/dL. Patients then proceed to maintenance therapy.
- Maintenance therapy: Patients receive epoetin alfa SC once every other week for up to 24 weeks of total treatment (including both initial therapy and maintenance therapy). Patients whose blood counts fall below the critical levels are placed on a weekly dosing schedule. Patients whose blood counts rise too high discontinue study drug until blood counts are reduced.
Quality of life (including fatigue) is assessed at baseline and then every 4 weeks for 28 weeks.
After completion of study therapy, patients are followed at 4 weeks.
PROJECTED ACCRUAL: A total of 25 patients will be accrued for this study.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Weekly Procrit (epoetin alfa) dosing | Active comparator | Drug: Weekly procrit dosingWeekly dosing schedule subjects will get the study drug once every week until the end of the study. |
| Interval Dosing (epoetin alfa) PK Group | Experimental | Drug: Interval DosingInterval-dosing schedule subjects will get the study drug once every week until hematocrit is greater than 36% or Hemoglobin reaches a value of 12 g/dl, then they will get study drug once every other week. Subjects who consented to pharmacokinetic testing |
| Interval Dosing (epoetin alfa) Non PK Group | Experimental | Drug: Interval DosingInterval-dosing schedule subjects will get the study drug once every week until hematocrit is greater than 36% or Hemoglobin reaches a value of 12 g/dl, then they will get study drug once every other week. Subjects who did not consent to pharmacokinetic testing. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (10 listed)
- Patient has uncontrolled hypertension
- Patient has history of symptomatic cardiac disease
- Patient has serious intercurrent illness
- The patient is pregnant, has a positive serum HCG or is lactating Patient has known hypersensitivity to mammalian cell-derived products or human albumin.
- Patient has diagnosis of polycythemia vera, chronic myelogenous leukemia, myelodysplastic syndrome
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 |
|---|---|---|
| Weekly procrit dosingThe dose is standard of care, the investigational piece is the dosing schedule itself. Either weekly or Interval-dosing schedule subjects will get the study drug once every week until hematocrit is greater than 36% or Hemoglobin reaches a value of 12 g/dl, then they will get study drug once every other week. | Drug | Weekly Procrit (epoetin alfa) dosing |
| Interval DosingThe dosing of Procrit is standard of care, it is the schedule that is the investigational piece. | Drug | Interval Dosing (epoetin alfa) Non PK Group, Interval Dosing (epoetin alfa) PK Group |
Primary outcome
Number of Subjects That Maintained Target Hemoglobin Level (11-12 g/dL) Maintenance Weekly for 12 Weeks
Time frame: 12 weeks
3 secondary outcomes
Pharmacokinetics (PK) and Pharmacodynamics Assays That Measure Concentration of Erythropoietin in Serum.
Time frame: every other week
Quality of Life at Baseline and Weeks 4, 8, 16, 24, and 28
Time frame: weeks 4,8,16,24 and 28
Number of Adverse Events (AEs) Experienced as Measure of Safety and Tolerability.
Time frame: On study, averaging 3 to 6 months.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Joseph Bubalo, PharmD, BCPS, BCOP principal investigator
OHSU Knight Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Weekly procrit dosing and Interval Dosing in people with Anemia and Fatigue, run by OHSU Knight Cancer Institute at 1 site in United States.
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 0 inclusion and 10 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 9 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 May 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Subjects That Maintained Target Hemoglobin Level (11-12 g/dL) Maintenance Weekly for 12 Weeks (time frame: 12 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 9 May 2017.