NCT00416624

Brief Summary

RATIONALE: Epoetin alfa and darbepoetin alfa may cause the body to make more red blood cells. They are used to treat anemia caused by chemotherapy in patients with cancer. PURPOSE: This randomized clinical trial is studying four different schedules of epoetin alfa or darbepoetin alfa to compare how well they work in treating patients with anemia caused by chemotherapy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
239

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started May 2007

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

First Submitted

Initial submission to the registry

December 27, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 28, 2006

Completed
4 months until next milestone

Study Start

First participant enrolled

May 1, 2007

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
7.7 years until next milestone

Results Posted

Study results publicly available

February 10, 2017

Completed
Last Updated

February 10, 2017

Status Verified

September 1, 2015

Enrollment Period

2.1 years

First QC Date

December 27, 2006

Results QC Date

September 10, 2015

Last Update Submit

December 19, 2016

Conditions

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

Keywords

unspecified adult solid tumor, protocol specificextramedullary plasmacytomaisolated plasmacytoma of bonerefractory multiple myelomastage I multiple myelomastage II multiple myelomastage III multiple myelomaWaldenstrom macroglobulinemiapost-transplant lymphoproliferative disorderstage I adult T-cell leukemia/lymphomastage II adult T-cell leukemia/lymphomastage III adult T-cell leukemia/lymphomastage IV adult T-cell leukemia/lymphomarecurrent adult T-cell leukemia/lymphomaAIDS-related peripheral/systemic lymphomaAIDS-related primary CNS lymphomaangioimmunoblastic T-cell lymphomaanaplastic large cell lymphomastage I cutaneous T-cell non-Hodgkin lymphomastage II cutaneous T-cell non-Hodgkin lymphomastage III cutaneous T-cell non-Hodgkin lymphomastage IV cutaneous T-cell non-Hodgkin lymphomarecurrent cutaneous T-cell non-Hodgkin lymphomastage I mycosis fungoides/Sezary syndromestage II mycosis fungoides/Sezary syndromestage III mycosis fungoides/Sezary syndromestage IV mycosis fungoides/Sezary syndromerecurrent mycosis fungoides/Sezary syndromestage I adult Hodgkin lymphomastage II adult Hodgkin lymphomastage III adult Hodgkin lymphomastage IV adult Hodgkin lymphomarecurrent adult Hodgkin lymphomaadult grade III lymphomatoid granulomatosisstage I adult Burkitt lymphomastage III adult Burkitt lymphomastage IV adult Burkitt 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 lymphomacontiguous 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 lymphomastage I adult diffuse large cell lymphomastage I adult diffuse mixed cell lymphomastage I adult diffuse small cleaved cell lymphomastage III adult diffuse large cell lymphomastage III adult diffuse mixed cell lymphomastage III adult diffuse small cleaved cell lymphomastage IV adult diffuse large cell lymphomastage IV adult diffuse mixed cell lymphomastage IV adult diffuse small cleaved cell lymphomastage I adult immunoblastic large cell lymphomastage III adult immunoblastic large cell lymphomastage IV adult immunoblastic large cell lymphomastage I adult lymphoblastic lymphomastage III adult lymphoblastic lymphomastage IV adult lymphoblastic lymphomastage I grade 1 follicular lymphomastage I grade 2 follicular lymphomastage I grade 3 follicular lymphomastage III grade 1 follicular lymphomastage III grade 2 follicular lymphomastage III grade 3 follicular lymphomastage IV grade 1 follicular lymphomastage IV grade 2 follicular lymphomastage IV grade 3 follicular lymphomastage I mantle cell lymphomastage I marginal zone lymphomastage III mantle cell lymphomastage III marginal zone lymphomastage IV mantle cell 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 Burkitt lymphomarecurrent adult diffuse large cell lymphomarecurrent adult diffuse mixed cell lymphomarecurrent adult diffuse small cleaved cell lymphomarecurrent adult grade III lymphomatoid granulomatosisrecurrent adult immunoblastic large cell lymphomarecurrent adult lymphoblastic lymphomarecurrent grade 1 follicular lymphomarecurrent grade 2 follicular lymphomarecurrent grade 3 follicular lymphomarecurrent mantle cell lymphomarecurrent marginal zone lymphomarecurrent small lymphocytic lymphomaadult acute lymphoblastic leukemia in remissionrecurrent adult acute lymphoblastic leukemiauntreated adult acute lymphoblastic leukemiastage I chronic lymphocytic leukemiastage II chronic lymphocytic leukemiastage III chronic lymphocytic leukemiastage IV chronic lymphocytic leukemiarefractory chronic lymphocytic leukemiarefractory hairy cell leukemiaprogressive hairy cell leukemia, initial treatmentprolymphocytic leukemiaanemiamonoclonal gammopathy of undetermined significanceprimary systemic amyloidosisT-cell large granular lymphocyte leukemiaacute undifferentiated leukemiamast cell leukemiaadult nasal type extranodal NK/T-cell lymphomauntreated hairy cell leukemia

Outcome Measures

Primary Outcomes (1)

  • The Percentage of Participants Who Exhibit a Hematopoietic Response

    A hematopoietic response was defined as Hb rise \>2 g/dL from baseline or achieving Hb ≥ 11.5 g/dL, whichever occurs first, in the absence of RBC transfusions within 14 days of measurement) during the treatment period

    20 weeks

Secondary Outcomes (11)

  • Weekly Change in Hemoglobin Levels

    Baseline and Week 4, 7, 10, 13, 16

  • Time Required to Achieve Hemoglobin Levels >= 11.5 g/dL

    16 weeks

  • Mean Hemoglobin Change From Week 1 to Week 16

    Week 1 and Week 16

  • The Percentage of Participants Requiring Red Blood Cell (RBC) Transfusions

    16 weeks

  • The Total RBC Transfusion Needed

    16 weeks

  • +6 more secondary outcomes

Study Arms (4)

Epoetin alfa - 40000 units

EXPERIMENTAL

40,000 Units

Drug: darbepoetin alfaDrug: epoetin alfaProcedure: fatigue assessment and managementProcedure: quality-of-life assessment

Epoetin alfa - 80000 units

EXPERIMENTAL

80,000 Units

Drug: darbepoetin alfaDrug: epoetin alfaProcedure: fatigue assessment and managementProcedure: quality-of-life assessment

Epoetin alfa - 120000 Units

EXPERIMENTAL

120,000 Units

Drug: darbepoetin alfaDrug: epoetin alfaProcedure: fatigue assessment and managementProcedure: quality-of-life assessment

Darbepoetin alfa***

EXPERIMENTAL

500 mcg

Drug: darbepoetin alfaDrug: epoetin alfaProcedure: fatigue assessment and managementProcedure: quality-of-life assessment

Interventions

darbepoetin alfaDRUG
Darbepoetin alfa***Epoetin alfa - 120000 UnitsEpoetin alfa - 40000 unitsEpoetin alfa - 80000 units
epoetin alfaDRUG
Darbepoetin alfa***Epoetin alfa - 120000 UnitsEpoetin alfa - 40000 unitsEpoetin alfa - 80000 units
fatigue assessment and managementPROCEDURE
Darbepoetin alfa***Epoetin alfa - 120000 UnitsEpoetin alfa - 40000 unitsEpoetin alfa - 80000 units
quality-of-life assessmentPROCEDURE
Darbepoetin alfa***Epoetin alfa - 120000 UnitsEpoetin alfa - 40000 unitsEpoetin alfa - 80000 units

Eligibility Criteria

Age18 Years - 120 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Diagnosis of solid tumor or nonmyeloid hematologic malignancy (e.g., plasma cell dyscrasia or lymphoproliferative disorder) * No nonmelanomatous skin cancer * Hemoglobin ≤ 10.5 g/dL * Ferritin \> 20 ng/mL (i.e., not obviously iron deficient) * Planning to receive ≥ 12 weeks of anticancer chemotherapy * Biological therapy (e.g., hypomethylating agents, monoclonal antibodies, or small molecule pathway inhibitors) with an individual or cumulative regimen incidence of grade 3 or 4 anemia \> 10% is considered chemotherapy for purposes of this study * No known anemia secondary to any of the following: * Cyanocobalamin (vitamin B\_12) or folic acid deficiency * Gastrointestinal bleeding within the past 2 weeks * Hemolysis * Myelodysplastic syndromes, myeloproliferative disorders, or acute myeloid leukemia * No primary hematologic disorder causing chronic moderate to severe anemia (e.g., congenital dyserythropoietic anemia, homozygous hemoglobin S disease or compound heterozygous sickling states, or thalassemia major) * Carriers of these disease states allowed provided they are not anemic prior to cancer diagnosis PATIENT CHARACTERISTICS: * ECOG performance status 0-2 * Life expectancy ≥ 6 months * Not pregnant or nursing * No delivery of a baby of ≥ 18 weeks estimated gestational age within the past 3 months (90 days) * Negative pregnancy test * Fertile patients must use effective contraception * Weight \> 40.0 kg and \< 150.0 kg * No known hypersensitivity to epoetin alfa, darbepoetin alfa, mammalian-cell derived products, or human albumin * No uncontrolled hypertension, defined as systolic blood pressure (BP) ≥ 180 mm Hg and/or diastolic BP ≥ 100 mm Hg, despite medical therapy * No pulmonary emboli and/or deep vein thrombosis within the past 12 months * Patients actively receiving warfarin for a minimum of 4 weeks are exempted from this requirement * Prior superficial thrombophlebitis allowed * No cerebrovascular accident, ischemic stroke, acute coronary syndrome (e.g., unstable angina or Q-wave or non-Q wave myocardial infarction), or other arterial or venous thrombotic events within the past 6 months * No history of chronic hypercoagulable disorders (e.g., activated protein C resistance, anti-cardiolipin disorder, protein C deficiency, or protein S deficiency) * Patients receiving anticoagulation therapy (warfarin or acetylsalicyclic acid \[aspirin\] at a dose of ≥ 325 mg/day) for these conditions are eligible provided therapy is continued during the study period * History of previously treated seizures allowed provided the patient has been seizure-free for a minimum of 3 months PRIOR CONCURRENT THERAPY: * See Disease Characteristics * More than 1 year since prior peripheral blood stem cell, bone marrow, or cord blood transplantation * More than 14 days since prior red blood cell transfusion * More than 14 days since prior major surgery, including, but not limited to, any of the following: * Amputation * Invasion of a body cavity or of the central nervous system using a scalpel, saw, or laser cutting tool * Resection of a body part (or parts), whether solid or liquid tissue or both, that includes ≥ 1% of a patient's preoperative weight * The following are not considered major surgery: * Diagnostic/therapeutic thoracentesis or paracentesis * Diagnostic skin biopsy * Digit or fingernail/thumbnail resection or laceration repair under local anesthesia * Diagnostic fat aspiration * Otic irrigation to remove cerumen impaction * Tympanocentesis * Uncomplicated dental extraction * Uncomplicated tonsillectomy * Laser corneal remodeling for refraction purposes * Cosmetic or therapeutic eyelid surgery * Bone marrow aspiration and biopsy * More than 10 weeks since prior darbepoetin alfa, epoetin alfa, or any investigational form of erythropoietin (e.g., gene-activated erythropoietin or novel erythropoiesis stimulating protein) * No planned stem cell transplantation within the next 4 months (18 weeks)

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

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

AnemiaLeukemiaLymphomaLymphoproliferative DisordersMultiple MyelomaNeoplasms, Plasma CellPrecancerous ConditionsWaldenstrom MacroglobulinemiaPrecursor T-Cell Lymphoblastic Leukemia-LymphomaImmunoblastic LymphadenopathyLymphoma, Large-Cell, AnaplasticLymphoma, T-Cell, CutaneousMycosis FungoidesSezary SyndromeHodgkin DiseaseBurkitt LymphomaLymphoma, Large B-Cell, DiffuseLymphoma, Non-HodgkinLymphoma, Large-Cell, ImmunoblasticPrecursor Cell Lymphoblastic Leukemia-LymphomaLymphoma, FollicularLymphoma, Mantle-CellLymphoma, B-Cell, Marginal ZoneLeukemia, Lymphocytic, Chronic, B-CellLeukemia, Hairy CellLeukemia, ProlymphocyticMonoclonal Gammopathy of Undetermined SignificanceImmunoglobulin Light-chain AmyloidosisLeukemia, Large Granular LymphocyticLeukemia, Biphenotypic, AcuteLeukemia, Mast-CellLymphoma, Extranodal NK-T-Cell

Interventions

Darbepoetin alfaEpoetin AlfaTherapeutics

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic DiseasesNeoplasms by Histologic TypeNeoplasmsLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHemorrhagic DisordersLeukemia, LymphoidLymphadenopathyLymphoma, T-CellEpstein-Barr Virus InfectionsHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsTumor Virus InfectionsLymphoma, B-CellLeukemia, B-CellChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsHypergammaglobulinemiaAmyloidosisProteostasis DeficienciesMetabolic DiseasesNutritional and Metabolic DiseasesLeukemia, T-CellLeukemia, Myeloid, AcuteLeukemia, MyeloidMastocytosis, SystemicMastocytosisMast Cell Activation Disorders

Intervention Hierarchy (Ancestors)

ErythropoietinColony-Stimulating FactorsGlycoproteinsGlycoconjugatesCarbohydratesProteinsAmino Acids, Peptides, and ProteinsHematopoietic Cell Growth FactorsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesBiological Factors

Results Point of Contact

Title
Charles L. Loprinzi, M.D.
Organization
Mayo Clinic
loprinzi.charles@mayo.edu
507-266-6247

Study Officials

  • Charles L. Loprinzi, M.D.

    Mayo Clinic

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
Yes

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

December 27, 2006

First Posted

December 28, 2006

Study Start

May 1, 2007

Primary Completion

June 1, 2009

Study Completion

June 1, 2009

Last Updated

February 10, 2017

Results First Posted

February 10, 2017

Record last verified: 2015-09

Locations

US(1)