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CompletedNCT00224068Updated Mar 2, 2012

Effect of Iron Therapy as an Adjunct to Epoetin Alfa in the Anemia of Cancer Chemotherapy

A Phase 4 interventional study of Sodium ferric gluconate, ferrous sulfate, standard of care in Anemia, sponsored by Watson Pharmaceuticals. Completed at 32 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-03-02.

Sponsored by Watson Pharmaceuticals · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
180
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Anemia

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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
03

In context

Anemia

1,733 studies on the registry are indexed under Anemia; 246 are open to participants now.

This study's enrollment of 180 is above the median of 94 across 1,291 interventional studies indexed under Anemia.

Browse Anemia studies →

Lead sponsor

Watson Pharmaceuticals is the lead sponsor of 30 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • Highly elevated TSAT or ferritin
  • Recent transfusion, epoetin alfa, darbepoetin or intravenous iron
  • Medical conditions that would confound the efficacy evaluation
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
180 participants

Interventions

  • DrugSodium ferric gluconate, ferrous sulfate, standard of care
06

What researchers measure

Primary outcomes

  1. Change in hemoglobin

Secondary outcomes

  1. Change in various iron indices

07

Study locations

32 sites
  • Bakersfield, California, United States
  • Chula Vista, California, United States
  • Long Beach, California, United States
  • Los Angeles, California, United States
  • Norwich, Connecticut, United States
  • Port St 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
  • Southfield, Michigan, United States
  • St Joseph, 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
08

References and documents

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 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 2, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00224068
Lead sponsor
Watson Pharmaceuticals
Responsible party
Sponsor
First posted
Sep 22, 2005
Start date
May 2002
Primary completion
Dec 2003
Completion
Dec 2003
Last update
Mar 2, 2012

Study contacts

Naomi V. Dahl, Pharm.D.
study director · Watson Laboratories, Inc.

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2012. You cannot join it, but the record below documents what was studied.

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