AnemiaPhase 3NCT00350090
A Study to Assess the Response Rate of PROCRIT (Epoetin Alfa) Given at a Dose of 40,000 Units Once a Week to Cancer Patients With Anemia Who Are Not Receiving Chemotherapy.
A Phase 3 study testing Epoetin Alfa in people with Anemia and Neoplasms, run by Ortho Biotech Products, L.P..
Trial summary
The purpose of this study is to evaluate the effectiveness and safety of PROCRIT (Epoetin alfa) administered at 40,000 Units weekly in cancer patients that 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
- 98 participants
- Where
- No sites listed yet
- Study dates
- Sep 2002to Mar 2004
- Phase
- Phase 3
- 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
- Baseline hemoglobin value of less than or equal to 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
- Uncontrolled hypertension
- History (within 6 months) of uncontrolled cardiac arrhythmias, or history of pulmonary emboli, deep vein thrombosis, ischemic stroke, other arterial or venous thrombotic events (excluding superficial thromboses), or known history of chronic coagulation disorder
- Transfusion within 28 days prior to first dose
- 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 40,000 Units Once Weekly in Anemic Cancer Patients Not Receiving Chemotherapy
The purpose of this study is to evaluate the effectiveness and safety of PROCRIT (Epoetin alfa) administered at 40,000 Units weekly in cancer patients that are not receiving chemotherapy or radiation therapy.
Read the detailed description
This is an open-label (both the researcher and the patient in the study know the treatment that is being given), non-randomized, multi-center pilot study with the objective to investigate the efficacy of PROCRIT (Epoetin alfa) with regard to hematopoietic response when administered at 40,000 Units subcutaneously (under the skin) once per week in anemic patients with cancer not receiving chemotherapy or radiation therapy. Hematological laboratory tests (hemoglobin and hematocrit), vital signs (blood pressure) and occurrence and severity of adverse events will be assessed throughout the study. Patients will receive a PROCRIT (Epoetin alfa) injection (40,000 Units per injection) under the skin once every week for a maximum of 13 weeks. Doses may be reduced depending on the patients' hemoglobin level.
- Being tested
- Epoetin Alfa
- Keywords
- Anemia, Neoplasms, Hemoglobin values
- 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.
Hematologic response in terms of hemoglobin and transfusion requirements where hemoglobin response is characterized as minor > 1g/dL Hb increase or major > 2g/dL Hb increase.
Secondary outcomes (1)
Secondary efficacy variables will include the effects of PROCRIT (Epoetin alfa) on transfusion requirements and on Quality of Life as measured by the Linear Analog Scale Assessment (LASA) tool.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2006 (estimated)
- Study startSep 2002
- Study completionMar 2004
Why it stopped: This study was stopped early due to slow enrollment.
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 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 98 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
- NCT00350090
- Sponsor's protocol ID
- CR005113
- Status last verified
- Mar 2010
- First submitted
- 7 Jul 2006
- Last updated
- 19 May 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Shasha D, Williams D. Weekly epoetin alfa treatment of anemia in patients with cancer not undergoing therapy. J Support Oncol. 2006 Mar;4(3):129-35.
PubMed 16553139
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 Pilot Study to Evaluate the Response Rate of PROCRIT (Epoetin Alfa) at 40,000 Units Once Weekly in Anemic Cancer Patients Not Receiving Chemotherapy
- ClinicalTrials.gov ID
- NCT00350090
- Acronym / sponsor ID
- CR005113
- Keywords
- Anemia, Neoplasms, Hemoglobin values
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: This study was stopped early due to slow enrollment.
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Ortho Biotech Products, L.P.Industry (pharma, biotech, devices)
- Study start
- Sep 2002
- Study completion
- Mar 2004 (actual)
- First posted
- 10 Jul 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 PROCRIT (Epoetin alfa) administered at 40,000 Units weekly in cancer patients that are not receiving chemotherapy or radiation therapy.
Detailed description
This is an open-label (both the researcher and the patient in the study know the treatment that is being given), non-randomized, multi-center pilot study with the objective to investigate the efficacy of PROCRIT (Epoetin alfa) with regard to hematopoietic response when administered at 40,000 Units subcutaneously (under the skin) once per week in anemic patients with cancer not receiving chemotherapy or radiation therapy. Hematological laboratory tests (hemoglobin and hematocrit), vital signs (blood pressure) and occurrence and severity of adverse events will be assessed throughout the study. Patients will receive a PROCRIT (Epoetin alfa) injection (40,000 Units per injection) under the skin once every week for a maximum of 13 weeks. Doses may be reduced 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)
- Histologically confirmed diagnosis of non-myeloid malignancy
- Baseline hemoglobin value of less than or equal to 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 (5 listed)
- Uncontrolled hypertension
- History (within 6 months) of uncontrolled cardiac arrhythmias, or history of pulmonary emboli, deep vein thrombosis, ischemic stroke, other arterial or venous thrombotic events (excluding superficial thromboses), or known history of chronic coagulation disorder
- Transfusion within 28 days prior to first dose
- 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
Hematologic response in terms of hemoglobin and transfusion requirements where hemoglobin response is characterized as minor > 1g/dL Hb increase or major > 2g/dL Hb increase.
1 secondary outcome
Secondary efficacy variables will include the effects of PROCRIT (Epoetin alfa) on transfusion requirements and on Quality of Life as measured by the Linear Analog Scale Assessment (LASA) tool.
Results and safety
The study was stopped early (reason given: This study was stopped early due to slow enrollment.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2011.
- Results publication: PubMed 16553139Shasha D, Williams D. Weekly epoetin alfa treatment of anemia in patients with cancer not undergoing therapy. J Support Oncol. 2006 Mar;4(3):129-35.
- A Pilot Study to Evaluate the Response Rate of PROCRIT (Epoetin alfa) at 40,000 Units Once Weekly in Anemic Cancer Patients 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.
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 3 study testing Epoetin Alfa in people with Anemia and Neoplasms, 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 5 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 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 early due to slow enrollment.). 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?
Hematologic response in terms of hemoglobin and transfusion requirements where hemoglobin response is characterized as minor > 1g/dL Hb increase or major > 2g/dL Hb increase.. 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 NCT00350090, 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.