NCT00270166

Brief Summary

The purpose of this study is to evaluate the safety and effectiveness of epoetin alfa versus placebo in reducing or preventing the need for transfusions in anemic patients with cancer receiving chemotherapy, and to investigate possible quality-of-life benefits associated with the use of epoetin alfa. Epoetin alfa is a genetically engineered protein that stimulates red blood cell production.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
201

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Feb 1995

Typical duration for phase_3

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

February 1, 1995

Completed
3.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 1998

Completed
7.6 years until next milestone

First Submitted

Initial submission to the registry

December 22, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 26, 2005

Completed
Last Updated

May 18, 2011

Status Verified

February 1, 2011

First QC Date

December 22, 2005

Last Update Submit

May 17, 2011

Conditions

AnemiaMultiple MyelomaLymphomaBreast CancerOvarian CancerCarcinoma, Small Cell LungEsophagus CancerProstate CancerNeoplasm

Keywords

cancermalignancyred cell transfusionepoetin alfaepoetinerythropoietinred blood cells

Outcome Measures

Primary Outcomes (1)

  • Proportion of patients without transfusion after first month.

Secondary Outcomes (1)

  • Proportion of responders, change of hemoglobin (not by transfusion), cumulative transfusion rate, proportion of patients transfused during the double-blind phase, excluding the first month; mean change score of baseline quality of life parameters; safety

Interventions

epoetin alfaDRUG

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Confirmed diagnosis of multiple myeloma, lymphoma, breast cancer, ovarian cancer, small-cell lung cancer, esophagus cancer, or prostate cancer
  • receiving treatment with chemotherapy, with at least 3 additional months of chemotherapy planned
  • a self-care performance score of 0 (fully active, no disease restriction) to 3 (capable of only limited self-care, confined to bed or chair more than 50% of waking hours)
  • life expectancy of at least 6 months
  • baseline hemoglobin \<12 grams per deciliter and baseline count of \<100,000 microliter for developing red cells

You may not qualify if:

  • Clinically significant disease other than cancer
  • evidence of uncontrolled hypertension or history of seizure
  • transfusion within 1 week of the study
  • radiotherapy within 2 weeks of study start
  • use of corticosteroid or steroid drugs during the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

AnemiaMultiple MyelomaLymphomaBreast NeoplasmsOvarian NeoplasmsSmall Cell Lung CarcinomaEsophageal NeoplasmsProstatic NeoplasmsNeoplasms

Interventions

Epoetin Alfa

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic DiseasesNeoplasms, Plasma CellNeoplasms by Histologic TypeHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHemorrhagic DisordersLymphoproliferative DisordersImmunoproliferative DisordersImmune System DiseasesLymphatic DiseasesNeoplasms by SiteBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesEndocrine Gland NeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal DisordersCarcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsLung DiseasesRespiratory Tract DiseasesGastrointestinal NeoplasmsDigestive System NeoplasmsHead and Neck NeoplasmsDigestive System DiseasesEsophageal DiseasesGastrointestinal DiseasesGenital Neoplasms, MaleGenital Diseases, MaleProstatic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial

    Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

December 22, 2005

First Posted

December 26, 2005

Study Start

February 1, 1995

Study Completion

May 1, 1998

Last Updated

May 18, 2011

Record last verified: 2011-02