AnemiaPhase 4NCT00224068
Effect of Iron Therapy as an Adjunct to Epoetin Alfa in the Anemia of Cancer Chemotherapy
A Phase 4 study of Anemia, run by Watson Pharmaceuticals at 32 sites in United States.
Trial summary
This study evaluates the safety and efficacy of Ferrlecit® (ferric gluconate; a form of intravenous iron) or ferrous sulfate (a form of oral iron) in improving the response to epoetin alfa among 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
- How many people
- 180 participants
- Where
- 32 sitesUnited States
- Study dates
- May 2002to Dec 2003
- 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
- Diagnosis of nonmyeloid malignancy
- Moderate to severe anemia
- Adequate iron stores as measured by either TSAT or ferritin
- About to start cycle of chemotherapy
- Eligible for epoetin alfa therapy
Who cannot join
- Highly elevated TSAT or ferritin
- Recent transfusion, epoetin alfa, darbepoetin or intravenous iron
- Medical conditions that would confound the efficacy evaluation
Trial locations and contacts
32 sites in 1 country.
32 sites in 1 country
United States32 sites
Study site
Bakersfield, California
Study site
Baltimore, Maryland
Study site
Baton Rouge, Louisiana
Study site
Bismarck, North Dakota
Study site
Cherry Hill, New Jersey
Study site
Chula Vista, California
Study site
Coeur d'Alene, Idaho
Study site
Columbia, South Carolina
Study site
Columbus, Georgia
Study site
Columbus, Ohio
Study site
Denville, New Jersey
Study site
Detroit, Michigan
Study site
Duluth, Minnesota
Study site
Greenwood, Mississippi
Study site
Hutchinson, Kansas
Study site
Laredo, Texas
Study site
Lexington, Kentucky
Study site
Long Beach, California
Study site
Los Angeles, California
Study site
Manhasset, New York
Study site
Milwaukee, Wisconsin
Study site
Norwich, Connecticut
Study site
Philadelphia, Pennsylvania
Study site
Pittsburgh, Pennsylvania
Study site
Port Saint Lucie, Florida
Study site
Richmond, Virginia
Study site
Saint Joseph, Michigan
Study site
Salem, Virginia
Study site
Southfield, Michigan
Study site
Walla Walla, Washington
Study site
West Chester, Pennsylvania
Study site
Zephyrhills, Florida
About this study
Official title: A Multicenter, Randomized, Controlled Prospective Trial of the Safety and Efficacy of Ferrlecit® in Anemic Cancer Patients Who Are Receiving Acute Chemotherapy and Epoetin as Compared to Oral Iron and No Treatment
This study evaluates the safety and efficacy of Ferrlecit® (ferric gluconate; a form of intravenous iron) or ferrous sulfate (a form of oral iron) in improving the response to epoetin alfa among anemic cancer patients receiving chemotherapy.
- Conditions
- Anemia
- Being tested
- Sodium ferric gluconate, ferrous sulfate, standard of care
- Keywords
- Iron deficiency, Sodium ferric gluconate, anemia, cancer chemotherapy, epoetin alfa, Anemia/drug therapy, Anemia, Iron-Deficiency/drug therapy/etiology, Hematinics/administration & dosage/pharmacology, Antineoplastic Agents/adverse effects, Erythropoietin, Recombinant/therapeutic use/adverse effects
- Medical subject headings
- Anemia, Iron Deficiencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sodium ferric gluconate, ferrous sulfate, standard of careDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in hemoglobin
Secondary outcomes (1)
Change in various iron indices
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startMay 2002
- Primary completionDec 2003
- Study completionDec 2003
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
- 180 participants
Sponsor and investigators
- Lead sponsor
- Watson Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Naomi V. Dahl, Pharm.D., Study director, Watson Laboratories, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00224068
- Sponsor's protocol ID
- FR01008
- Status last verified
- Feb 2012
- First submitted
- 13 Sep 2005
- Last updated
- 2 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Henry DH, Dahl NV, Auerbach M, Tchekmedyian S, Laufman LR. Intravenous ferric gluconate significantly improves response to epoetin alfa versus oral iron or no iron in anemic patients with cancer receiving chemotherapy. Oncologist. 2007 Feb;12(2):231-42. doi: 10.1634/theoncologist.12-2-231.
PubMed 17296819
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Controlled Prospective Trial of the Safety and Efficacy of Ferrlecit® in Anemic Cancer Patients Who Are Receiving Acute Chemotherapy and Epoetin as Compared to Oral Iron and No Treatment
- ClinicalTrials.gov ID
- NCT00224068
- Acronym / sponsor ID
- FR01008
- Conditions
- Anemia
- Keywords
- Iron deficiency, Sodium ferric gluconate, anemia, cancer chemotherapy, epoetin alfa, Anemia/drug therapy, Anemia, Iron-Deficiency/drug therapy/etiology, Hematinics/administration & dosage/pharmacology
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants
- Lead sponsor
- Watson PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- May 2002
- Primary completion
- Dec 2003 (actual)
- Study completion
- Dec 2003 (actual)
- First posted
- 22 Sep 2005 (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.
This study evaluates the safety and efficacy of Ferrlecit® (ferric gluconate; a form of intravenous iron) or ferrous sulfate (a form of oral iron) in improving the response to epoetin alfa among anemic cancer patients receiving chemotherapy.
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 (5 listed)
- Diagnosis of nonmyeloid malignancy
- Moderate to severe anemia
- Adequate iron stores as measured by either TSAT or ferritin
- About to start cycle of chemotherapy
- Eligible for epoetin alfa therapy
Key exclusion criteria (3 listed)
- Highly elevated TSAT or ferritin
- Recent transfusion, epoetin alfa, darbepoetin or intravenous iron
- Medical conditions that would confound the efficacy evaluation
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 |
|---|---|---|
| Sodium ferric gluconate, ferrous sulfate, standard of care | Drug | – |
Primary outcome
Change in hemoglobin
1 secondary outcome
Change in various iron indices
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 2 Mar 2012.
- Results publication: PubMed 17296819Henry DH, Dahl NV, Auerbach M, Tchekmedyian S, Laufman LR. Intravenous ferric gluconate significantly improves response to epoetin alfa versus oral iron or no iron in anemic patients with cancer receiving chemotherapy. Oncologist. 2007 Feb;12(2):231-42. doi: 10.1634/theoncologist.12-2-231.
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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.
Naomi V. Dahl, Pharm.D. study director
Watson Laboratories, Inc.
32 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study of Anemia, run by Watson Pharmaceuticals at 32 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 3 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 2 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 32 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 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?
Change in hemoglobin. 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 NCT00224068, 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 2 Mar 2012.