Epoetin Alfa or Epoetin Beta With or Without Iron Infusion in Treating Anemia in Patients With Cancer - Full Text View

Sponsored by:	St. Bartholomew's Hospital
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00482716

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
Cancer-Related Problem/Condition Leukemia Lymphoma Multiple Myeloma and Plasma Cell Neoplasm Unspecified Adult Solid Tumor, Protocol Specific	Drug: epoetin alfa Drug: epoetin beta Drug: iron dextran complex Drug: iron sucrose injection	Phase III

Genetics Home Reference related topics: aceruloplasminemia hemophilia

MedlinePlus related topics: Anemia Cancer Leukemia, Adult Acute Leukemia, Adult Chronic Leukemia, Childhood Lymphoma Multiple Myeloma

Drug Information available for: Epoetin alfa Erythropoietin Epoetin beta Sucrose Dextrans Ferric oxide, saccharated Iron-dextran complex

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Supportive Care, Randomized, Open Label, Active Control
Official Title:	Randomized Controlled Study of Iron Supplementation to Support the Response to Recombinant Human Erythropoietin for the Treatment of Chemotherapy-Induced Anaemia

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

Detailed Description:

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, England
Saint Bartholomew's Hospital	Recruiting
London, England, United Kingdom, EC1A 7BE
Contact: Samir G Agrawal, MD, PhD 44-207-601-8202 s.g.agrawal@qmul.ac.uk

Sponsors and Collaborators

St. Bartholomew's Hospital

Investigators

Study Chair:

Samir G Agrawal, MD, PhD

St. Bartholomew's Hospital

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Study ID Numbers:	CDR0000549549, BARTS-06/Q0605/93, ISRCTN11830961, EU-20731
Study First Received:	June 4, 2007
Last Updated:	November 13, 2008
ClinicalTrials.gov Identifier:	NCT00482716
Health Authority:	Unspecified

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

Study placed in the following topic categories:

Iron-Dextran Complex
Epoetin Alfa
Leukemia, Lymphoid
Blood Protein Disorders
Lymphoma, Follicular
Lymphoma, small cleaved-cell, diffuse
Lymphoma, B-Cell, Marginal Zone
Paraproteinemias
Hemostatic Disorders
Lymphoma, B-Cell
Ferric oxide, saccharated
Leukemia
Hemorrhagic Disorders
Multiple myeloma
Leukemia, Lymphocytic, Chronic, B-Cell

Lymphoma
Dextrans
Chronic lymphocytic leukemia
Immunoproliferative Disorders
Hematologic Diseases
Leukemia, B-cell, chronic
Blood Coagulation Disorders
Anemia
Vascular Diseases
Recurrence
Multiple Myeloma
Lymphatic Diseases
B-cell lymphomas
Lymphoproliferative Disorders
Lymphoma, Non-Hodgkin

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Histologic Type
Immune System Diseases
Hematinics
Growth Substances
Therapeutic Uses

Physiological Effects of Drugs
Hematologic Agents
Trace Elements
Cardiovascular Diseases
Micronutrients
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009