NCT00255749

Brief Summary

RATIONALE: Epoetin alfa may cause the body to make more red blood cells. It is used to treat anemia caused by cancer and chemotherapy. PURPOSE: This randomized phase II trial is studying how well epoetin alfa works in treating patients with anemia who are undergoing chemotherapy for cancer.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
89

participants targeted

Target at P50-P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2005

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

November 18, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 21, 2005

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2007

Completed
Last Updated

October 4, 2012

Status Verified

October 1, 2012

Enrollment Period

1.7 years

First QC Date

November 18, 2005

Last Update Submit

October 3, 2012

Conditions

AnemiaLeukemiaLymphomaLymphoproliferative DisorderMultiple Myeloma and Plasma Cell NeoplasmPrecancerous ConditionUnspecified Adult Solid Tumor, Protocol Specific

Keywords

adult acute lymphoblastic leukemia in remissionprogressive hairy cell leukemia, initial treatmentstage 0 chronic lymphocytic leukemiaanemiaextramedullary plasmacytomaisolated plasmacytoma of bonerefractory multiple myelomamonoclonal gammopathy of undetermined significanceprimary systemic amyloidosisstage I multiple myelomastage II multiple myelomastage III multiple myelomaAIDS-related peripheral/systemic lymphomaAIDS-related primary CNS lymphomaanaplastic large cell lymphomaangioimmunoblastic T-cell lymphomaextranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissuenodal marginal zone B-cell lymphomarecurrent adult Burkitt lymphomarecurrent adult diffuse large cell lymphomarecurrent adult diffuse mixed cell lymphomarecurrent adult diffuse small cleaved cell lymphomarecurrent adult Hodgkin lymphomarecurrent adult immunoblastic large cell lymphomarecurrent adult lymphoblastic lymphomarecurrent adult T-cell leukemia/lymphomarecurrent cutaneous T-cell non-Hodgkin lymphomarecurrent grade 1 follicular lymphomarecurrent grade 2 follicular lymphomarecurrent grade 3 follicular lymphomarecurrent mantle cell lymphomarecurrent marginal zone lymphomarecurrent mycosis fungoides/Sezary syndromerecurrent small lymphocytic lymphomasplenic marginal zone lymphomastage III adult Burkitt lymphomastage III adult diffuse large cell lymphomastage III adult diffuse mixed cell lymphomastage III adult diffuse small cleaved cell lymphomastage III adult Hodgkin lymphomastage III adult immunoblastic large cell lymphomastage III adult lymphoblastic lymphomastage III adult T-cell leukemia/lymphomastage III cutaneous T-cell non-Hodgkin lymphomastage III grade 1 follicular lymphomastage III grade 2 follicular lymphomastage III grade 3 follicular lymphomastage III mantle cell lymphomastage III marginal zone lymphomastage III mycosis fungoides/Sezary syndromestage III small lymphocytic lymphomastage IV adult Burkitt lymphomastage IV adult diffuse large cell lymphomastage IV adult diffuse mixed cell lymphomastage IV adult diffuse small cleaved cell lymphomastage IV adult Hodgkin lymphomastage IV adult immunoblastic large cell lymphomastage IV adult lymphoblastic lymphomastage IV adult T-cell leukemia/lymphomastage IV cutaneous T-cell non-Hodgkin lymphomastage IV grade 1 follicular lymphomastage IV grade 2 follicular lymphomastage IV grade 3 follicular lymphomastage IV mantle cell lymphomastage IV marginal zone lymphomastage IV mycosis fungoides/Sezary syndromestage IV small lymphocytic lymphomaWaldenström macroglobulinemiacontiguous stage II adult Burkitt lymphomacontiguous stage II adult diffuse large cell lymphomacontiguous stage II adult diffuse mixed cell lymphomacontiguous stage II adult diffuse small cleaved cell lymphomacontiguous stage II adult immunoblastic large cell lymphomacontiguous stage II adult lymphoblastic lymphomacontiguous stage II grade 1 follicular lymphomacontiguous stage II grade 2 follicular lymphomacontiguous stage II grade 3 follicular lymphomacontiguous stage II mantle cell lymphomacontiguous stage II marginal zone lymphomacontiguous stage II small lymphocytic lymphomanoncontiguous stage II adult Burkitt lymphomanoncontiguous stage II adult diffuse large cell lymphomanoncontiguous stage II adult diffuse mixed cell lymphomanoncontiguous stage II adult diffuse small cleaved cell lymphomanoncontiguous stage II adult immunoblastic large cell lymphomanoncontiguous stage II adult lymphoblastic lymphomanoncontiguous stage II grade 1 follicular lymphomanoncontiguous stage II grade 2 follicular lymphomanoncontiguous stage II grade 3 follicular lymphomanoncontiguous stage II mantle cell lymphomanoncontiguous stage II marginal zone lymphomanoncontiguous stage II small lymphocytic lymphomapost-transplant lymphoproliferative disorderstage I adult Burkitt lymphomastage I adult diffuse large cell lymphomastage I adult diffuse mixed cell lymphomastage I adult diffuse small cleaved cell lymphomastage I adult Hodgkin lymphomastage I adult immunoblastic large cell lymphomastage I adult lymphoblastic lymphomastage I adult T-cell leukemia/lymphomastage I cutaneous T-cell non-Hodgkin lymphomastage I grade 1 follicular lymphomastage I grade 2 follicular lymphomastage I grade 3 follicular lymphomastage I mantle cell lymphomastage I marginal zone lymphomastage I small lymphocytic lymphomastage II adult Hodgkin lymphomastage II adult T-cell leukemia/lymphomastage II cutaneous T-cell non-Hodgkin lymphomastage I mycosis fungoides/Sezary syndromestage II mycosis fungoides/Sezary syndromerecurrent adult acute lymphoblastic leukemiarefractory chronic lymphocytic leukemiastage I chronic lymphocytic leukemiastage II chronic lymphocytic leukemiastage III chronic lymphocytic leukemiastage IV chronic lymphocytic leukemiarefractory hairy cell leukemiaprolymphocytic leukemiaunspecified adult solid tumor, protocol specificT-cell large granular lymphocyte leukemia

Outcome Measures

Primary Outcomes (2)

  • Efficacy

    7 weeks

  • Safety

    7 weeks

Secondary Outcomes (1)

  • Quality of life

    7 weeks

Study Arms (2)

early intervention epoietin alfa

EXPERIMENTAL

Patients receive epoetin alfa subcutaneously on day 1. Treatment repeats every 21 days for up to 5 courses.

Biological: epoetin alfa

standard intervention epoietin alfa

OTHER

Patients receive epoetin alfa as in arm I once their hemoglobin level is ≤ 10.5 g/dL.

Biological: epoetin alfa

Interventions

epoetin alfaBIOLOGICAL
early intervention epoietin alfastandard intervention epoietin alfa

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically confirmed nonmyeloid cancer * No history of myelodysplasia * Baseline hemoglobin 11-12 g/dL * No anemia due to factors other than cancer or chemotherapy (e.g., iron, cyanocobalamin \[vitamin B\_12\], or folate deficiencies, hemolysis, or gastrointestinal bleeding) * Receiving chemotherapy that meets the following criteria: * Administered weekly OR every 3 weeks * Must begin chemotherapy on or before the first day of study treatment * No known, untreated CNS metastases PATIENT CHARACTERISTICS: Performance status * ECOG 0-2 Life expectancy * At least 6 months Hematopoietic * See Disease Characteristics * Absolute neutrophil count ≥ 1,000/mm\^3 * Platelet count ≥ 100,000/mm\^3 (transfusion independent) * Iron transferrin saturation \> 20% * No history of chronic hypercoagulable disorders (e.g., activated protein C resistance, anti-cardiolipin disorder, protein C deficiency, or protein S deficiency) Hepatic * Bilirubin \< 2.0 mg/dL * SGPT ≤ 3 times upper limit of normal Renal * Creatinine ≤ 1.5 mg/dL * No significant, uncontrolled genitourinary disease or dysfunction Cardiovascular * No uncontrolled cardiac arrhythmia in the past 6 months * No uncontrolled hypertension * No deep vein thrombosis, ischemic stroke, or other arterial or venous thrombotic events * Superficial thromboses allowed * No other significant, uncontrolled cardiovascular disease or dysfunction Pulmonary * No significant, uncontrolled pulmonary disease or dysfunction * No pulmonary emboli Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No infection requiring hospitalization or antibiotics in the past 14 days * No known hypersensitivity to mammalian cell-derived products or to human albumin * No new onset (in the past 3 months) poorly controlled seizures * No other active malignancy except basal cell carcinoma or carcinoma in situ * Not an employee of the investigator or study center or family members of the employee or the investigator * No significant, uncontrolled neurological, endocrine, or gastrointestinal disease or dysfunction PRIOR CONCURRENT THERAPY: Biologic therapy * See Chemotherapy * More than 3 months since prior erythropoietic agent (e.g., epoetin alfa, darbepoetin alfa, or gene-activated erythropoietin) * More than 4 weeks since prior packed red blood cell transfusion * No concurrent stem cell harvest of bone marrow * No concurrent interleukin-11 * No other concurrent erythropoietic agent Chemotherapy * See Disease Characteristics * No concurrent high-dose chemotherapy with stem cell transplantation Radiotherapy * No concurrent nonpalliative radiotherapy Surgery * More than 2 weeks since prior major surgery Other * At least 1 month since prior investigational agents or devices * No concurrent high-dose IV iron supplementation

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

Sponsors & Collaborators

Study Sites (1)

Jonsson Comprehensive Cancer Center at UCLA

Los Angeles, California, 90095-1781, United States

Location

Related Publications (1)

  • Glaspy JA, Charu V, Luo D, Moyo V, Kamin M, Wilhelm FE. Initiation of epoetin-alpha therapy at a starting dose of 120,000 units once every 3 weeks in patients with cancer receiving chemotherapy: an open-label, multicenter study with randomized and nonrandomized treatment arms. Cancer. 2009 Mar 1;115(5):1121-31. doi: 10.1002/cncr.24127.

    PMID: 19170225DERIVED

MeSH Terms

Conditions

AnemiaLeukemiaLymphomaLymphoproliferative DisordersMultiple MyelomaNeoplasms, Plasma CellPrecancerous ConditionsLeukemia, Lymphocytic, Chronic, B-CellMonoclonal Gammopathy of Undetermined SignificanceImmunoglobulin Light-chain AmyloidosisLymphoma, Large-Cell, AnaplasticImmunoblastic LymphadenopathyLymphoma, B-Cell, Marginal ZoneBurkitt LymphomaLymphoma, Large B-Cell, DiffuseLymphoma, Non-HodgkinHodgkin DiseaseLymphoma, Large-Cell, ImmunoblasticPrecursor Cell Lymphoblastic Leukemia-LymphomaPrecursor T-Cell Lymphoblastic Leukemia-LymphomaLymphoma, T-Cell, CutaneousLymphoma, FollicularLymphoma, Mantle-CellMycosis FungoidesSezary SyndromeWaldenstrom MacroglobulinemiaLeukemia, Hairy CellLeukemia, ProlymphocyticLeukemia, Large Granular Lymphocytic

Interventions

Epoetin Alfa

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic DiseasesNeoplasms by Histologic TypeNeoplasmsLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHemorrhagic DisordersLeukemia, B-CellLeukemia, LymphoidChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsHypergammaglobulinemiaAmyloidosisProteostasis DeficienciesMetabolic DiseasesNutritional and Metabolic DiseasesLymphoma, T-CellLymphadenopathyLymphoma, B-CellEpstein-Barr Virus InfectionsHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsTumor Virus InfectionsLeukemia, T-Cell

Intervention Hierarchy (Ancestors)

ErythropoietinColony-Stimulating FactorsGlycoproteinsGlycoconjugatesCarbohydratesHematopoietic Cell Growth FactorsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological Factors

Study Officials

  • John A. Glaspy, MD, MPH

    Jonsson Comprehensive Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 18, 2005

First Posted

November 21, 2005

Study Start

August 1, 2005

Primary Completion

April 1, 2007

Last Updated

October 4, 2012

Record last verified: 2012-10

Locations

US(1)