Effect of Iron Therapy as an Adjunct to Epoetin Alfa in the Anemia of Cancer Chemotherapy
NCT ID: NCT00224068
Last Updated: 2012-03-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
180 participants
INTERVENTIONAL
2002-05-31
2003-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Interventions
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Sodium ferric gluconate, ferrous sulfate, standard of care
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* Recent transfusion, epoetin alfa, darbepoetin or intravenous iron
* Medical conditions that would confound the efficacy evaluation
18 Years
ALL
No
Sponsors
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Watson Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Naomi V. Dahl, Pharm.D.
Role: STUDY_DIRECTOR
Watson Laboratories, Inc.
Locations
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Bakersfield, California, United States
Chula Vista, California, United States
Long Beach, California, United States
Los Angeles, California, United States
Norwich, Connecticut, United States
Port Saint Lucie, Florida, United States
Zephyrhills, Florida, United States
Columbus, Georgia, United States
Coeur d'Alene, Idaho, United States
Hutchinson, Kansas, United States
Lexington, Kentucky, United States
Baton Rouge, Louisiana, United States
Baltimore, Maryland, United States
Detroit, Michigan, United States
Saint Joseph, Michigan, United States
Southfield, Michigan, United States
Duluth, Minnesota, United States
Greenwood, Mississippi, United States
Cherry Hill, New Jersey, United States
Denville, New Jersey, United States
Manhasset, New York, United States
Bismarck, North Dakota, United States
Columbus, Ohio, United States
Philadelphia, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
West Chester, Pennsylvania, United States
Columbia, South Carolina, United States
Laredo, Texas, United States
Richmond, Virginia, United States
Salem, Virginia, United States
Walla Walla, Washington, United States
Milwaukee, Wisconsin, United States
Countries
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References
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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.
Other Identifiers
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FR01008
Identifier Type: -
Identifier Source: org_study_id
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