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

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-05-31

Study Completion Date

2003-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Anemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Sodium ferric gluconate, ferrous sulfate, standard of care

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* Highly elevated TSAT or ferritin
* Recent transfusion, epoetin alfa, darbepoetin or intravenous iron
* Medical conditions that would confound the efficacy evaluation
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Watson Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Chula Vista, California, United States

Site Status

Long Beach, California, United States

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Los Angeles, California, United States

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Norwich, Connecticut, United States

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Port Saint Lucie, Florida, United States

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Zephyrhills, Florida, United States

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Columbus, Georgia, United States

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Coeur d'Alene, Idaho, United States

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Hutchinson, Kansas, United States

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Lexington, Kentucky, United States

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Baton Rouge, Louisiana, United States

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Baltimore, Maryland, United States

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Detroit, Michigan, United States

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Saint Joseph, Michigan, United States

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Southfield, Michigan, United States

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Duluth, Minnesota, United States

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Greenwood, Mississippi, United States

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Cherry Hill, New Jersey, United States

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Denville, New Jersey, United States

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Manhasset, New York, United States

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Bismarck, North Dakota, United States

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Columbus, Ohio, United States

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Philadelphia, Pennsylvania, United States

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Pittsburgh, Pennsylvania, United States

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West Chester, Pennsylvania, United States

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Columbia, South Carolina, United States

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Laredo, Texas, United States

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Richmond, Virginia, United States

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Salem, Virginia, United States

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Walla Walla, Washington, United States

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Milwaukee, Wisconsin, United States

Site Status

Countries

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United States

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.

Reference Type RESULT
PMID: 17296819 (View on PubMed)

Other Identifiers

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FR01008

Identifier Type: -

Identifier Source: org_study_id

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