Back to resultsEffect of Iron Therapy as an Adjunct to Epoetin Alfa in the Anemia of Cancer Chemotherapy
Primary Purpose
Anemia
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Sodium ferric gluconate, ferrous sulfate, standard of care
Sponsored by
About this trial
This is an interventional treatment trial for Anemia focused on measuring 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
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
Sites / Locations
Outcomes
Primary Outcome Measures
Change in hemoglobin
Secondary Outcome Measures
Change in various iron indices
Full Information
NCT ID
NCT00224068
First Posted
September 13, 2005
Last Updated
February 29, 2012
Sponsor
Watson Pharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT00224068
Brief Title
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
2. Study Status
Record Verification Date
February 2012
Overall Recruitment Status
Completed
Study Start Date
May 2002 (undefined)
Primary Completion Date
December 2003 (Actual)
Study Completion Date
December 2003 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Watson Pharmaceuticals
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
180 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Sodium ferric gluconate, ferrous sulfate, standard of care
Primary Outcome Measure Information:
Title
Change in hemoglobin
Secondary Outcome Measure Information:
Title
Change in various iron indices
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Naomi V. Dahl, Pharm.D.
Organizational Affiliation
Watson Laboratories, Inc.
Official's Role
Study Director
Facility Information:
City
Bakersfield
State/Province
California
Country
United States
City
Chula Vista
State/Province
California
Country
United States
City
Long Beach
State/Province
California
Country
United States
City
Los Angeles
State/Province
California
Country
United States
City
Norwich
State/Province
Connecticut
Country
United States
City
Port St Lucie
State/Province
Florida
Country
United States
City
Zephyrhills
State/Province
Florida
Country
United States
City
Columbus
State/Province
Georgia
Country
United States
City
Coeur d'Alene
State/Province
Idaho
Country
United States
City
Hutchinson
State/Province
Kansas
Country
United States
City
Lexington
State/Province
Kentucky
Country
United States
City
Baton Rouge
State/Province
Louisiana
Country
United States
City
Baltimore
State/Province
Maryland
Country
United States
City
Detroit
State/Province
Michigan
Country
United States
City
Southfield
State/Province
Michigan
Country
United States
City
St Joseph
State/Province
Michigan
Country
United States
City
Duluth
State/Province
Minnesota
Country
United States
City
Greenwood
State/Province
Mississippi
Country
United States
City
Cherry Hill
State/Province
New Jersey
Country
United States
City
Denville
State/Province
New Jersey
Country
United States
City
Manhasset
State/Province
New York
Country
United States
City
Bismarck
State/Province
North Dakota
Country
United States
City
Columbus
State/Province
Ohio
Country
United States
City
Philadelphia
State/Province
Pennsylvania
Country
United States
City
Pittsburgh
State/Province
Pennsylvania
Country
United States
City
West Chester
State/Province
Pennsylvania
Country
United States
City
Columbia
State/Province
South Carolina
Country
United States
City
Laredo
State/Province
Texas
Country
United States
City
Richmond
State/Province
Virginia
Country
United States
City
Salem
State/Province
Virginia
Country
United States
City
Walla Walla
State/Province
Washington
Country
United States
City
Milwaukee
State/Province
Wisconsin
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
17296819
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.
Results Reference
result
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Effect of Iron Therapy as an Adjunct to Epoetin Alfa in the Anemia of Cancer Chemotherapy
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