Epoetin Alfa or Epoetin Beta With or Without Iron Infusion in Treating Anemia in Patients With Cancer
The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2009 by National Cancer Institute (NCI).
Recruitment status was Active, not recruiting
Recruitment status was Active, not recruiting
Sponsor:
St. Bartholomew's Hospital
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00482716
First received: June 4, 2007
Last updated: August 18, 2009
Last verified: August 2009
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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 | Intervention | 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 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Masking: 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 |
Resource links provided by NLM:
MedlinePlus related topics:
Anemia
Cancer
Chronic Lymphocytic Leukemia
Iron
Leukemia
Lymphoma
Multiple Myeloma
U.S. FDA Resources
Further study details as provided by National Cancer Institute (NCI):
Primary Outcome Measures:
- Maximum hemoglobin achieved
Secondary Outcome Measures:
- Time to zenith hemoglobin or achievement of hemoglobin level ≥ 13 g/dL
| Estimated Enrollment: | 80 |
| Study Start Date: | January 2007 |
OBJECTIVES:
- 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.
Eligibility| Ages Eligible for Study: | 16 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
DISEASE CHARACTERISTICS:
Diagnosis of nonmyeloid malignancy
- No primary bone marrow malignancies except multiple myeloma, chronic lymphocytic leukemia, or indolent non-Hodgkin lymphoma
Candidate for erythropoietin stimulatory activity therapy for anemia due to cancer and/or chemotherapy
- Baseline hemoglobin ≤ 10.5 g/dL
- Planning to receive ≥ 6 additional weeks of chemotherapy for the malignancy
Demonstrates iron-replete status as defined by all of the following parameters:
- Percent saturation of transferrin ≥ 20%
- Serum ferritin 225-2,250 pmol/L
- Reticulocyte hemoglobin content > 31 pg
- Zinc protoporphyrin < 80 µg/dL
- No anemia of origin other than cancer or cancer chemotherapy
PATIENT CHARACTERISTICS:
- ECOG performance status 0-2
- No allergy or intolerance to recombinant epoetin alfa or epoetin beta
- No known sensitivity to iron sucrose injection or iron dextran complex
- No uncontrolled hypertension
- No active infection
- No active bleeding
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No prior iron sucrose injection or iron dextran complex therapy
- More than 6 months since prior and no concurrent transfusion
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00482716
Locations
| United Kingdom | |
| Saint Bartholomew's Hospital | |
| London, England, United Kingdom, EC1A 7BE | |
Sponsors and Collaborators
St. Bartholomew's Hospital
Investigators
| Study Chair: | Samir G Agrawal, MD, PhD | St. Bartholomew's Hospital |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00482716 History of Changes |
| Other Study ID Numbers: | CDR0000549549, BARTS-06/Q0605/93, ISRCTN11830961, EU-20731 |
| Study First Received: | June 4, 2007 |
| Last Updated: | August 18, 2009 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
unspecified adult solid tumor, protocol specific refractory multiple myeloma stage I multiple myeloma stage II multiple myeloma stage III multiple myeloma noncontiguous stage II adult diffuse small cleaved cell lymphoma noncontiguous stage II grade 1 follicular lymphoma noncontiguous stage II grade 2 follicular lymphoma noncontiguous stage II marginal zone lymphoma noncontiguous stage II small lymphocytic lymphoma contiguous stage II adult diffuse small cleaved cell lymphoma contiguous stage II grade 1 follicular lymphoma contiguous stage II grade 2 follicular lymphoma contiguous stage II marginal zone lymphoma contiguous stage II small lymphocytic lymphoma |
stage I adult diffuse small cleaved cell lymphoma stage III adult diffuse small cleaved cell lymphoma stage IV adult diffuse small cleaved cell lymphoma stage I grade 1 follicular lymphoma stage I grade 2 follicular lymphoma stage III grade 1 follicular lymphoma stage III grade 2 follicular lymphoma stage IV grade 1 follicular lymphoma stage IV grade 2 follicular lymphoma stage I marginal zone lymphoma stage III marginal zone lymphoma stage IV marginal zone lymphoma stage I small lymphocytic lymphoma stage III small lymphocytic lymphoma stage IV small lymphocytic lymphoma |
Additional relevant MeSH terms:
|
Anemia Neoplasms Leukemia Lymphoma Lymphoma, Non-Hodgkin Multiple Myeloma Neoplasms, Plasma Cell Plasmacytoma Hematologic Diseases Neoplasms by Histologic Type Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Hemostatic Disorders |
Vascular Diseases Cardiovascular Diseases Paraproteinemias Blood Protein Disorders Hemorrhagic Disorders Dextrans Epoetin Alfa Iron-Dextran Complex Ferric oxide, saccharated Iron Anticoagulants Hematologic Agents Therapeutic Uses Pharmacologic Actions Plasma Substitutes |
ClinicalTrials.gov processed this record on June 17, 2013