NCT00216541

Brief Summary

The purpose of this study is to evaluate the effect of early treatment with epoetin alfa in addition to best standard of care on hemoglobin levels and the need for red blood cell transfusions in cancer patients receiving chemotherapy as compared to patients receiving standard epoetin alfa treatment and best standard of care.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
110

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Aug 2003

Typical duration for phase_4

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
2.1 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 22, 2005

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2006

Completed
Last Updated

May 19, 2011

Status Verified

June 1, 2010

First QC Date

September 13, 2005

Last Update Submit

May 18, 2011

Conditions

AnemiaNeoplasms

Keywords

Anemiacancertransfusionchemotherapyhemoglobinstandard careepoetin alfaepoetinerythropoietin

Outcome Measures

Primary Outcomes (1)

  • Change in hemoglobin from the start of the study to 3 or 4, 8 or 9, and 12 weeks, and at the end of the treatment period

Secondary Outcomes (1)

  • Number of patients who receive an allogenic blood transfusion during the study

Interventions

epoetin alfaDRUG

Eligibility Criteria

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

You may qualify if:

  • Confirmed diagnosis of cancer and planned to receive chemotherapy in 1, 2, 3, or 4 weekly schedules for a minimum of 8 weeks
  • have a hemoglobin level of \>10 grams per deciliter and \<= 12 grams per deciliter within 14 days before the start of the first on-study chemotherapy cycle
  • Eastern Cooperative Oncology Group (scale used by researchers to represent the level of activity a patient is capable of) score of 0 (able to carry out all normal activity without restriction) to 2 (ambulatory and capable of all self-care but unable to carry out any work)
  • life expectancy of \>=6 months
  • female subjects postmenopausal for at least 1 year, surgically sterile or practicing an effective method of birth control

You may not qualify if:

  • Clinically significant or uncontrolled disease/dysfunction of any body system that is not due to cancer or chemotherapy, including uncontrolled or severe cardiovascular disease, recent (\< 6 months) myocardial infarction, uncontrolled high blood pressure, congestive heart failure, or uncontrolled or unexplained history of seizures
  • planned surgery expected to influence hemoglobin levels, within the first 8 or 9 weeks of study entry
  • major illness or infection within 1 month of study entry
  • highly increased risk of thrombotic or other vascular events
  • androgen therapy within 2 months of study entry
  • anemia due to factors other than cancer/chemotherapy (e.g., severe hemolysis, gastrointestinal bleeding, or myelodysplastic syndromes)
  • blood transfusion within 14 days prior to study entry
  • pregnant or lactating females

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Schouwink JH, Codrington H, Sleeboom HP, Kerkhofs LG, Wormhoudt LW. Prevention of anaemia by early intervention with once weekly epoetin alfa during chemotherapy. Eur J Cancer. 2008 Apr;44(6):819-29. doi: 10.1016/j.ejca.2008.02.017. Epub 2008 Mar 17.

    PMID: 18343652RESULT

Related Links

MeSH Terms

Conditions

AnemiaNeoplasms

Interventions

Epoetin Alfa

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Janssen-Cilag B.V. Clinical Trial

    Janssen-Cilag B.V.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 22, 2005

Study Start

August 1, 2003

Study Completion

September 1, 2006

Last Updated

May 19, 2011

Record last verified: 2010-06