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
Phase 4
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Anemia
Both
Anemia
Trial Information
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
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Change in hemoglobin
Safety Issue:
No
Principal Investigator
Naomi V. Dahl, Pharm.D.
Investigator Role:
Study Director
Investigator Affiliation:
Watson Laboratories, Inc.
Authority:
United States: Food and Drug Administration
Study ID:
FR01008
NCT ID:
NCT00224068
Start Date:
May 2002
Completion Date:
December 2003
Related Keywords:
- Anemia
- 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
- Anemia
Name | Location |
|---|---|
| New Britain, Connecticut 06052 | |
| Alexandria, Minnesota 56308 | |
| Albany, Georgia 31701 | |
| Fountain Valley, California 92708 | |
| Miami, Florida 33176 | |
| Albany, New York 12208 | |
| Cleveland, Ohio 44195 | |
| Philadelphia, Pennsylvania 19104 | |
| Austin, Texas 78705 | |
| Seattle, Washington 98195 | |
| Flint, Michigan 48532 | |
| Louisville, Kentucky 40207 | |
| McLean, Virginia 22101 | |
| Kansas City, Kansas 66160 | |
| Hackensack, New Jersey 07601 | |
| Metairie, Louisiana 70006 | |
| Baltimore, Maryland 21287 | |
| Milwaukee, Wisconsin | |
| Charleston, South Carolina | |
| Jackson, Mississippi | |
| Bismarck, North Dakota 58501 | |
| Coeur D'alene, Idaho 83814 |
