Epoetin Alfa or Epoetin Beta With or Without Iron Infusion in Treating Anemia in Patients With Cancer
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|ClinicalTrials.gov Identifier: NCT00482716|
Recruitment Status : Unknown
Verified August 2009 by National Cancer Institute (NCI).
Recruitment status was: Active, not recruiting
First Posted : June 5, 2007
Last Update Posted : January 10, 2014
RATIONALE: Epoetin alfa and epoetin beta may cause the body to make more red blood cells. Red blood cells contain iron that is needed to carry oxygen to the tissues. It is not yet known whether epoetin alfa or epoetin beta are more effective when given with or without iron infusion in treating anemia in patients with cancer.
PURPOSE: This randomized phase III trial is studying epoetin alfa or epoetin beta to compare how well they work with or without iron infusion in treating anemia in patients with cancer.
|Condition or disease||Intervention/treatment||Phase|
|Anemia Leukemia Lymphoma Multiple Myeloma and Plasma Cell Neoplasm Unspecified Adult Solid Tumor, Protocol Specific||Biological: epoetin alfa Biological: epoetin beta Dietary Supplement: iron dextran complex Dietary Supplement: iron sucrose injection||Phase 3|
- Compare the efficacy of recombinant epoetin alfa or epoetin beta with vs without parenteral iron in anemic, iron-replete patients with nonmyeloid malignancies.
OUTLINE: This is a randomized, controlled, open-label, prospective study. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive recombinant erythropoietic stimulatory activity (ESA) therapy comprising epoetin alfa or epoetin beta subcutaneously (SC) on day 1.
- Arm II: Patients receive ESA therapy as in arm I and parenteral iron (i.e., low molecular weight iron dextran complex IV over 5-10 minutes or iron sucrose injection IV over 10-30 minutes) on day 1.
In both arms, treatment repeats weekly for up to 10 weeks or until hemoglobin reaches 13 g/dL, whichever comes first.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Randomized Controlled Study of Iron Supplementation to Support the Response to Recombinant Human Erythropoietin for the Treatment of Chemotherapy-Induced Anaemia|
|Study Start Date :||January 2007|
- Maximum hemoglobin achieved
- Time to zenith hemoglobin or achievement of hemoglobin level ≥ 13 g/dL
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00482716
|Saint Bartholomew's Hospital|
|London, England, United Kingdom, EC1A 7BE|
|Study Chair:||Samir G Agrawal, MD, PhD||St. Bartholomew's Hospital|