AnemiaPhase 3NCT00083434
Treatment of Anemic Patients With Cancer Who Are Not Receiving Chemotherapy or Radiotherapy
A Phase 3 study testing Epoetin alfa in people with Anemia and Cancer, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C. at 6 sites in United States.
Trial summary
The purpose of this study is to examine the effectiveness of epoetin alfa in treating anemia in patients who have cancer or who no longer have any signs of the cancer, but remain anemic as a result of their treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Epoetin alfa
- How many people
- Not given
- Where
- 6 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
- 18 years of age or older
- Body weight >/= 99lbs
- 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
- History of or concurrent second malignancy
- Evidence of primary or metastatic malignancy involving the Central Nervous System
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Advanced Urology Medical Center
Anaheim, California, 92801
Shapiro, Stafford & Yee
Arcadia, California, 91007
California Cancer Center
Fresno, California, 93720
Tukoi Research
North Miami, Florida, 33161
Madigan Army Medical Center Urology Services
Tacoma, Washington, 98431-5000
Hanover Medical Specialists, PA
Wilmington, North Carolina, 28401
About this study
The purpose of this study is to examine the effectiveness of epoetin alfa in treating anemia in patients who have cancer or who no longer have any signs of the cancer, but remain anemic as a result of their treatment.
- Being tested
- Epoetin alfa
- Keywords
- Anemia, Cancer
- 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2004 (estimated)
- Study startFeb 2004
- Study completionOct 2004
Why it stopped: This study was stopped because of an inadequate rate of enrollment.
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
- NCT00083434
- Sponsor's protocol ID
- CR010549
- Other IDs
- EPO-CAN-303
- Status last verified
- Apr 2011
- First submitted
- 24 May 2004
- Last updated
- 27 Apr 2011
- Results posted
- No
- Data monitoring committee
- Yes
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 Anemic Patients With Cancer Who Are Not Receiving Chemotherapy or Radiotherapy
- ClinicalTrials.gov ID
- NCT00083434
- Acronym / sponsor ID
- CR010549
- Keywords
- Anemia, Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: This study was stopped because of an inadequate rate of enrollment.
- 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
- 26 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 examine the effectiveness of epoetin alfa in treating anemia in patients who have cancer or who no longer have any signs of the cancer, but remain anemic as a result of their treatment.
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 (5 listed)
- 18 years of age or older
- Body weight >/= 99lbs
- 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 (2 listed)
- History of or concurrent second malignancy
- Evidence of primary or metastatic malignancy involving the Central Nervous System
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 (reason given: This study was stopped because of an inadequate rate of enrollment.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2011.
- FDA Approved Product labeling, refer to the following link:http://www.accessdata.fda.gov/scripts/cder/drugsatfda/Link provided by the sponsor.
- Additional information is provided at the following link:http://dailymed.nlm.nih.gov/dailymed/about.cfmLink 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.
The record lists no contact. Use the official record to reach the sponsor.
6 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 and Cancer, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C. at 6 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 5 inclusion and 2 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 6 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 (reason given: This study was stopped because of an inadequate rate of 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.
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.