NCT00482716

Brief Summary

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at below P25 for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2007

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 4, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 5, 2007

Completed
Last Updated

January 10, 2014

Status Verified

August 1, 2009

First QC Date

June 4, 2007

Last Update Submit

January 9, 2014

Conditions

AnemiaLeukemiaLymphomaMultiple Myeloma and Plasma Cell NeoplasmUnspecified Adult Solid Tumor, Protocol Specific

Keywords

unspecified adult solid tumor, protocol specificrefractory multiple myelomastage I multiple myelomastage II multiple myelomastage III multiple myelomanoncontiguous stage II adult diffuse small cleaved cell lymphomanoncontiguous stage II grade 1 follicular lymphomanoncontiguous stage II grade 2 follicular lymphomanoncontiguous stage II marginal zone lymphomanoncontiguous stage II small lymphocytic lymphomacontiguous stage II adult diffuse small cleaved cell lymphomacontiguous stage II grade 1 follicular lymphomacontiguous stage II grade 2 follicular lymphomacontiguous stage II marginal zone lymphomacontiguous stage II small lymphocytic lymphomastage I adult diffuse small cleaved cell lymphomastage III adult diffuse small cleaved cell lymphomastage IV adult diffuse small cleaved cell lymphomastage I grade 1 follicular lymphomastage I grade 2 follicular lymphomastage III grade 1 follicular lymphomastage III grade 2 follicular lymphomastage IV grade 1 follicular lymphomastage IV grade 2 follicular lymphomastage I marginal zone lymphomastage III marginal zone lymphomastage IV marginal zone lymphomastage I small lymphocytic lymphomastage III small lymphocytic lymphomastage IV small lymphocytic lymphomaextranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissuenodal marginal zone B-cell lymphomasplenic marginal zone lymphomarecurrent adult diffuse small cleaved cell lymphomarecurrent grade 1 follicular lymphomarecurrent grade 2 follicular lymphomarecurrent marginal zone lymphomarecurrent small lymphocytic lymphomastage I chronic lymphocytic leukemiastage II chronic lymphocytic leukemiastage III chronic lymphocytic leukemiastage IV chronic lymphocytic leukemiarefractory chronic lymphocytic leukemiaanemia

Outcome Measures

Primary Outcomes (1)

  • Maximum hemoglobin achieved

Secondary Outcomes (1)

  • Time to zenith hemoglobin or achievement of hemoglobin level ≥ 13 g/dL

Interventions

epoetin alfaBIOLOGICAL
epoetin betaBIOLOGICAL
iron dextran complexDIETARY_SUPPLEMENT
iron sucrose injectionDIETARY_SUPPLEMENT

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Saint Bartholomew's Hospital

London, England, EC1A 7BE, United Kingdom

Location

MeSH Terms

Conditions

AnemiaLeukemiaLymphomaMultiple MyelomaNeoplasms, Plasma CellLymphoma, Non-HodgkinLymphoma, FollicularLymphoma, B-Cell, Marginal ZoneLeukemia, Lymphocytic, Chronic, B-Cell

Interventions

Epoetin Alfaepoetin betaIron-Dextran ComplexFerric Oxide, Saccharated

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic DiseasesNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHemorrhagic DisordersLymphoma, B-CellLeukemia, B-CellLeukemia, LymphoidChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

ErythropoietinColony-Stimulating FactorsGlycoproteinsGlycoconjugatesCarbohydratesHematopoietic Cell Growth FactorsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological FactorsCoordination ComplexesOrganic ChemicalsDextransGlucansPolysaccharidesFerric CompoundsIron CompoundsInorganic ChemicalsGlucaric AcidSugar AcidsAcids, AcyclicCarboxylic AcidsHydroxy Acids

Study Officials

  • Samir G Agrawal, MD, PhD

    St. Bartholomew's Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 4, 2007

First Posted

June 5, 2007

Study Start

January 1, 2007

Last Updated

January 10, 2014

Record last verified: 2009-08

Locations

GB(1)