NCT00264108

Brief Summary

The purpose of this study is to evaluate the cost-effectiveness of epoetin alfa compared with darbepoetin alfa in the treatment of anemia in adults receiving chemotherapy for cancer. Epoetin alfa and darbepoetin alfa are genetically engineered proteins that stimulate red blood cell production.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
492

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2005

Longer than P75 for all trials

Geographic Reach
1 country

20 active sites

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

June 1, 2005

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

December 9, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 12, 2005

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2011

Completed
Last Updated

May 7, 2014

Status Verified

May 1, 2014

Enrollment Period

5.7 years

First QC Date

December 9, 2005

Last Update Submit

May 6, 2014

Conditions

AnemiaNeoplasms

Keywords

Antineoplastic agentsChemotherapyCost-effectivenessEpoetin alfaDarbepoetin alfa

Outcome Measures

Primary Outcomes (1)

  • Cost-effectiveness based on: cancer type and status, chemotherapy and other anti-cancer treatment, hemoglobin levels, use of either epoetin alfa or darbepoetin alfa, use of blood transfusions, serum iron levels and iron supplementation.

    4 weeks, 8 weeks and end of treatment

Secondary Outcomes (1)

  • Safety evaluations including the incidence of serious and non-serious adverse events.

    from start of (Darb)epoetin treatment to end of study.

Study Arms (2)

1

Epoetin alfa 40 000 IU once weekly variable treatment length.

Drug: Epoetin alfa

2

Darbepoetin alfa Either 150 ug once weekly or 500 ug once every 3 wks variable treatment length.

Drug: Darbepoetin alfa

Interventions

Darbepoetin alfaDRUG

Either 150 ug once weekly or 500 ug once every 3 wks, variable treatment length.

2
Epoetin alfaDRUG

40,000 IU once weekly, variable treatment length.

1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Cancer patients receiving epoetin- or darbepoetin alfa as anemia treatment during chemotherapy, as part of the common practice of participating physicians. Patients may enter the study as soon as either their epoetin alfa or their darbepoetin alfa treatment starts.

You may qualify if:

  • Patients with a diagnosis of solid tumors, multiple myeloma (Kahlers' disease), non-Hodgkin lymphoma or Hodgkins' disease
  • Patients must already be receiving chemotherapy or start their first cycle within a week of enrollment
  • Patients must receive either epoetin alfa or darbepoetin alfa treatment (expected treatment duration is at least 4 weeks)

You may not qualify if:

  • Patients who cannot read the Dutch language and/or do not understand the Dutch Informed Consent Form

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (20)

Unknown Facility

's-Hertogenbosch, Netherlands

Location

Unknown Facility

Amstelveen, Netherlands

Location

Unknown Facility

Amsterdam, Netherlands

Location

Unknown Facility

Bergen op Zoom, Netherlands

Location

Unknown Facility

Den Helder, Netherlands

Location

Unknown Facility

Dirksland, Netherlands

Location

Unknown Facility

Ede Gld, Netherlands

Location

Unknown Facility

Eindhoven, Netherlands

Location

Unknown Facility

Goes, Netherlands

Location

Unknown Facility

Gorinchem, Netherlands

Location

Unknown Facility

Helmond, Netherlands

Location

Unknown Facility

Hoofddorp, Netherlands

Location

Unknown Facility

Meppel, Netherlands

Location

Unknown Facility

Purmerend, Netherlands

Location

Unknown Facility

Rotterdam, Netherlands

Location

Unknown Facility

Spijkenisse, Netherlands

Location

Unknown Facility

Tilburg, Netherlands

Location

Unknown Facility

Utrecht, Netherlands

Location

Unknown Facility

Winterswijk, Netherlands

Location

Unknown Facility

Zeist, Netherlands

Location

MeSH Terms

Conditions

AnemiaNeoplasms

Interventions

Darbepoetin alfaEpoetin Alfa

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Janssen-Cilag B.V. Clinical Trial

    Janssen-Cilag B.V.

    STUDY DIRECTOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 9, 2005

First Posted

December 12, 2005

Study Start

June 1, 2005

Primary Completion

February 1, 2011

Study Completion

February 1, 2011

Last Updated

May 7, 2014

Record last verified: 2014-05

Locations

NL(20)