AnemiaPhase 3NCT00083486
Treatment of Anemia in Patients With Cancer Who Are Not Currently Receiving Chemotherapy or Radiotherapy
A Phase 3 study testing epoetin alfa in people with Anemia, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C. at 12 sites in United States.
Trial summary
The purpose of this study is to determine the effectiveness of different doses of epoetin alfa for treating anemia in patients who have cancer; or patients who no longer have any signs of cancer, but remain anemic as a result of their treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anemia
- What is being tested?
- epoetin alfa
- How many people
- Not given
- Where
- 12 sitesUnited States
- Study dates
- Feb 2004to Oct 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
- Body weight >/=99 lbs
- ECOG 0-2
- Anemia results from cancer, chemotherapy, radiotherapy or an association with hormonal therapy or immunotherapy
- Screening hemoglobin level of </=11.0 g/dL for men or </=10.0 for women
Who cannot join
None listed.
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites
Caroline Cancer Center
Aiken, South Carolina, 29403
Southern Illinois Hematology
Centralia, Illinois, 62801
Charleston Hematology Oncology
Charleston, South Carolina, 29403
Charleston Cancer Care
Charleston, South Carolina, 29406
Mid Ohio Oncology Hematology
Columbus, Ohio, 43213
NorthEast Urology Research
Concord, North Carolina
Spalding Oncology Services
Griffin, Georgia, 30224
Heritage Physician Group-Oncology
Hot Springs, Arkansas, 71913
Volunteer Research Group
Knoxville, Tennessee, 37920
Slocum-Dickson Medical Group, PC
New Hartford, New York, 13413
Drexel University College of Medicine
Philadelphia, Pennsylvania, 19102
BioLab Research
Rockville, Maryland, 20852
About this study
The purpose of this study is to determine the effectiveness of different doses of epoetin alfa for treating anemia in patients who have cancer; or patients who no longer have any signs of cancer, but remain anemic as a result of their treatment. These patients should not be currently receiving chemotherapy or radiotherapy. A subject's participation in the study will last approximately 6 months. Subjects will receive weekly doses of epoetin alfa or placebo. Their hemoglobin will be tested every week.
- Conditions
- Anemia
- Being tested
- 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2004 (estimated)
- Study startFeb 2004
- Study completionOct 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 3
- Primary purpose
- Treatment
Sponsor and investigators
- Lead sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00083486
- Sponsor's protocol ID
- CR010939
- Other IDs
- EPO-CAN-203
- Status last verified
- Apr 2011
- First submitted
- 24 May 2004
- Last updated
- 27 Apr 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Anemia in Patients With Cancer Who Are Not Currently Receiving Chemotherapy or Radiotherapy
- ClinicalTrials.gov ID
- NCT00083486
- Acronym / sponsor ID
- CR010939
- Conditions
- Anemia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Terminated
- Lead sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.Industry (pharma, biotech, devices)
- Study start
- Feb 2004
- Study completion
- Oct 2004 (actual)
- First posted
- 27 May 2004 (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 determine the effectiveness of different doses of epoetin alfa for treating anemia in patients who have cancer; or patients who no longer have any signs of cancer, but remain anemic as a result of their treatment. These patients should not be currently receiving chemotherapy or radiotherapy. A subject's participation in the study will last approximately 6 months. Subjects will receive weekly doses of epoetin alfa or placebo. Their hemoglobin will be tested every week.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Body weight >/=99 lbs
- ECOG 0-2
- Anemia results from cancer, chemotherapy, radiotherapy or an association with hormonal therapy or immunotherapy
- Screening hemoglobin level of </=11.0 g/dL for men or </=10.0 for women
Key exclusion criteria (0 listed)
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
Not reported in the source record.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2011.
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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.
The record lists no contact. Use the official record to reach the sponsor.
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing epoetin alfa in people with Anemia, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C. at 12 sites 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 4 inclusion and 0 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 27 Apr 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites 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.
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. 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.
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 27 Apr 2011.