Clinical trial NCT00224068: Effect of Iron Therapy as an Adjunct to Epoetin Alfa in the Anemia of Cancer Chemotherapy
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
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
Antineoplastic Agents/adverse effects
Erythropoietin, Recombinant/therapeutic use/adverse effects
Lead sponsor: Watson Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2005-09-22
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in hemoglobin
Secondary outcomes:
measure: Change in various iron indices
Other outcomes:
Locations:
city: Bakersfield
country: United States
state: California
city: Chula Vista
country: United States
state: California
city: Long Beach
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: Norwich
country: United States
state: Connecticut
city: Port St Lucie
country: United States
state: Florida
city: Zephyrhills
country: United States
state: Florida
city: Columbus
country: United States
state: Georgia
city: Coeur d'Alene
country: United States
state: Idaho
city: Hutchinson
country: United States
state: Kansas
city: Lexington
country: United States
state: Kentucky
city: Baton Rouge
country: United States
state: Louisiana
city: Baltimore
country: United States
state: Maryland
city: Detroit
country: United States
state: Michigan
city: Southfield
country: United States
state: Michigan
city: St Joseph
country: United States
state: Michigan
city: Duluth
country: United States
state: Minnesota
city: Greenwood
country: United States
state: Mississippi
city: Cherry Hill
country: United States
state: New Jersey
city: Denville
country: United States
state: New Jersey
city: Manhasset
country: United States
state: New York
city: Bismarck
country: United States
state: North Dakota
city: Columbus
country: United States
state: Ohio
city: Philadelphia
country: United States
state: Pennsylvania
city: Pittsburgh
country: United States
state: Pennsylvania
city: West Chester
country: United States
state: Pennsylvania
city: Columbia
country: United States
state: South Carolina
city: Laredo
country: United States
state: Texas
city: Richmond
country: United States
state: Virginia
city: Salem
country: United States
state: Virginia
city: Walla Walla
country: United States
state: Washington
city: Milwaukee
country: United States
state: Wisconsin
Study officials:
affiliation: Watson Laboratories, Inc.
name: Naomi V. Dahl, Pharm.D.
role: STUDY_DIRECTOR
References:
citation: 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.