NCT00070382

Brief Summary

RATIONALE: Darbepoetin alfa and epoetin alfa may stimulate red blood cell production and treat anemia in patients who are receiving chemotherapy. It is not yet known whether darbepoetin alfa is more effective than epoetin alfa in treating patients with anemia. PURPOSE: Randomized phase III trial to compare the effectiveness of darbepoetin alfa with that of epoetin alfa in treating anemia in patients who are receiving chemotherapy for cancer.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
14

participants targeted

Target at below P25 for phase_3

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, 2003

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 3, 2003

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 7, 2003

Completed
25 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2003

Completed
Last Updated

August 3, 2020

Status Verified

August 1, 2012

Enrollment Period

3 months

First QC Date

October 3, 2003

Last Update Submit

July 30, 2020

Conditions

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

Keywords

anemiaunspecified adult solid tumor, protocol specificWaldenstrom macroglobulinemiamonoclonal gammopathy of undetermined significanceextramedullary plasmacytomaisolated plasmacytoma of bonerefractory multiple myelomaprimary systemic amyloidosisstage I multiple myelomastage II multiple myelomastage III multiple myelomapost-transplant lymphoproliferative disorderangioimmunoblastic 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 adult T-cell leukemia/lymphomastage I adult T-cell leukemia/lymphomastage II adult T-cell leukemia/lymphomastage III adult T-cell leukemia/lymphomastage IV adult T-cell leukemia/lymphomarecurrent cutaneous T-cell non-Hodgkin lymphomarecurrent mycosis fungoides/Sezary syndromestage I mycosis fungoides/Sezary syndromestage II mycosis fungoides/Sezary syndromestage III mycosis fungoides/Sezary syndromestage IV mycosis fungoides/Sezary syndromerecurrent adult Hodgkin lymphomastage I adult Hodgkin lymphomastage II adult Hodgkin lymphomastage III adult Hodgkin lymphomastage IV adult Hodgkin lymphomaT-cell large granular lymphocyte leukemiarefractory chronic lymphocytic leukemiastage 0 chronic lymphocytic leukemiastage I chronic lymphocytic leukemiastage II chronic lymphocytic leukemiastage III chronic lymphocytic leukemiastage IV chronic lymphocytic leukemiaprolymphocytic leukemiarecurrent grade 1 follicular lymphomarecurrent grade 2 follicular lymphomarecurrent grade 3 follicular 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 lymphomacontiguous stage II adult diffuse large cell lymphomacontiguous stage II adult diffuse mixed cell lymphomacontiguous stage II adult diffuse small cleaved cell lymphomanoncontiguous stage II adult diffuse large cell lymphomanoncontiguous stage II adult diffuse mixed cell lymphomanoncontiguous stage II adult diffuse small cleaved cell lymphomarecurrent adult diffuse large cell lymphomarecurrent adult diffuse mixed cell lymphomarecurrent adult diffuse small cleaved cell 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 lymphomacontiguous stage II adult immunoblastic large cell lymphomanoncontiguous stage II adult immunoblastic large cell lymphomarecurrent adult immunoblastic large cell lymphomastage I adult immunoblastic large cell lymphomastage III adult immunoblastic large cell lymphomastage IV adult immunoblastic large cell lymphomacontiguous stage II mantle cell lymphomanoncontiguous stage II mantle cell lymphomarecurrent mantle cell lymphomastage I mantle cell lymphomastage III mantle cell lymphomastage IV mantle cell lymphomacontiguous stage II grade 1 follicular lymphomacontiguous stage II grade 2 follicular lymphomacontiguous stage II grade 3 follicular lymphomanoncontiguous stage II grade 1 follicular lymphomanoncontiguous stage II grade 2 follicular lymphomanoncontiguous stage II grade 3 follicular lymphoma

Outcome Measures

Primary Outcomes (1)

  • Compare Efficacy of darbepoetin alfa with Epoetin Alfa as measured by the incidence of red blood cell transfusions.

    12 weeks

Study Arms (2)

Darbepoetin alfa

EXPERIMENTAL

darbepoetin alfa administered once every two weeks at a dose of 200 ug over a 16 week treatment period.

Drug: darbepoetin alfa

Epoetin alfa

ACTIVE COMPARATOR

epoetin alfa administered at 40,000 unites, once per week over a 16-week treatment period.

Drug: epoetin alfa

Interventions

darbepoetin alfaDRUG

darbepoetin alfa administered at a dose of 200ug once every 2 weeks over a 16-week treatment period

Darbepoetin alfa
epoetin alfaDRUG

epoetin alfa administered at a dose of 40,000U once every week over a 16-week treatment period

Epoetin alfa

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of a non-myeloid malignancy
  • Currently receiving or planning to receive at least 8 weeks of cyclic cytotoxic chemotherapy
  • Hemoglobin no greater than 11.0 g/dL
  • and over
  • ECOG 0-2
  • Bilirubin less than 2 times upper limit of normal (ULN)
  • Creatinine less than 2 times ULN
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • HIV negative
  • More than 30 days since prior darbepoetin alfa or epoetin alfa
  • More than 30 days since prior participation in investigational device or drug trials

You may not qualify if:

  • The following diagnoses are excluded:
  • Acute myeloid leukemia
  • Chronic myeloid leukemia
  • Acute lymphoblastic leukemia
  • Hairy cell leukemia
  • Burkitt's lymphoma
  • Lymphoblastic lymphoma
  • other primary hematologic disorder that would cause anemia (e.g., sickle cell anemia)
  • angina
  • congestive heart failure
  • New York Heart Association class III or IV heart disease
  • hypertension
  • cardiac arrhythmia
  • other unstable or uncontrolled disease or condition that would affect cardiac function
  • pregnant or nursing
  • +8 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jonsson Comprehensive Cancer Center, UCLA

Los Angeles, California, 90095, United States

Location

Related Publications (1)

  • 20030125 Study Group Trial; Glaspy J, Vadhan-Raj S, Patel R, Bosserman L, Hu E, Lloyd RE, Boccia RV, Tomita D, Rossi G. Randomized comparison of every-2-week darbepoetin alfa and weekly epoetin alfa for the treatment of chemotherapy-induced anemia: the 20030125 Study Group Trial. J Clin Oncol. 2006 May 20;24(15):2290-7. doi: 10.1200/JCO.2005.03.8570.

    PMID: 16710026RESULT

MeSH Terms

Conditions

AnemiaLeukemiaLymphomaLymphoproliferative DisordersMultiple MyelomaNeoplasms, Plasma CellPrecancerous ConditionsWaldenstrom MacroglobulinemiaMonoclonal Gammopathy of Undetermined SignificanceImmunoglobulin Light-chain AmyloidosisImmunoblastic LymphadenopathyLymphoma, Large-Cell, AnaplasticLymphoma, T-Cell, CutaneousPrecursor T-Cell Lymphoblastic Leukemia-LymphomaMycosis FungoidesSezary SyndromeHodgkin DiseaseLeukemia, Large Granular LymphocyticLeukemia, Lymphocytic, Chronic, B-CellLeukemia, ProlymphocyticLymphoma, FollicularLymphoma, Large B-Cell, DiffuseLymphoma, Non-HodgkinLymphoma, Large-Cell, ImmunoblasticLymphoma, Mantle-Cell

Interventions

Darbepoetin alfaEpoetin Alfa

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic DiseasesNeoplasms by Histologic TypeNeoplasmsLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHemorrhagic DisordersHypergammaglobulinemiaAmyloidosisProteostasis DeficienciesMetabolic DiseasesNutritional and Metabolic DiseasesLymphadenopathyLymphoma, T-CellPrecursor Cell Lymphoblastic Leukemia-LymphomaLeukemia, LymphoidLeukemia, T-CellLeukemia, B-CellChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsLymphoma, B-Cell

Intervention Hierarchy (Ancestors)

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

Study Officials

  • John A. Glaspy, MD, MPH

    Jonsson Comprehensive Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 3, 2003

First Posted

October 7, 2003

Study Start

August 1, 2003

Primary Completion

November 1, 2003

Last Updated

August 3, 2020

Record last verified: 2012-08

Locations

US(1)