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
Effect of Iron Therapy as an Adjunct to Epoetin Alfa in the Anemia of Cancer Chemotherapy
Sponsors
Source
Watson Pharmaceuticals
Oversight Info
Has Dmc
No
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.
Overall Status
Completed
Start Date
2002-05-01
Completion Date
2003-12-01
Primary Completion Date
2003-12-01
Phase
Phase 4
Study Type
Interventional
Primary Outcome
Measure |
|
Change in hemoglobin |
Secondary Outcome
Measure |
|
Change in various iron indices |
Enrollment
180
Condition
Intervention
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
Gender
All
Minimum Age
18 Years
Maximum Age
N/A
Healthy Volunteers
No
Overall Official
Last Name |
Role |
Affiliation |
|
Naomi V. Dahl, Pharm.D. |
Study Director |
Watson Laboratories, Inc. |
Location
Facility |
|
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 |
Location Countries
Country
United States
Verification Date
2012-02-01
Lastchanged Date
N/A
Firstreceived Date
N/A
Responsible Party
Responsible Party Type
Sponsor
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
, 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 Has Expanded Access
No
Condition Browse
Intervention Browse
Mesh Term
Iron
Epoetin Alfa
Ferric gluconate
Ferric Compounds
Results Reference
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.
PMID
17296819
Firstreceived Results Date
N/A
Firstreceived Results Disposition Date
N/A
Study Design Info
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)
Study First Submitted
September 13, 2005
Study First Submitted Qc
September 13, 2005
Study First Posted
September 22, 2005
Last Update Submitted
February 29, 2012
Last Update Submitted Qc
February 29, 2012
Last Update Posted
March 2, 2012
ClinicalTrials.gov processed this data on December 09, 2019
Conditions
Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov,
conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions
Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied.
Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase
Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions
that study is seeking to answer:
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.