Cost-effectiveness Study of Epoetin Alfa and Darbepoetin Alfa in Adult Patients With Cancer Who Have Anemia

May 6, 2014 updated by: Janssen-Cilag B.V.

EPREX (Epoetin Alfa) Versus ARANESP (Darbepoetin Alfa): Looking at Outcome of Anemia Treatment and Comparing Cost-effectiveness (EVALUATE).

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.

Study Overview

Status

Completed

Conditions

Detailed Description

Anemia has been identified as a common complication and a widespread problem in the cancer population. Anemia is a condition in which a patient has below normal levels of hemoglobin, the substance in red blood cells that carries oxygen to all parts of the body. People with severe anemia may experience fatigue and shortness of breath with activity. Therefore, this condition can have a negative influence on a person's quality of life. Epoetin alfa and darbepoetin alfa, used to treat anemia in cancer patients, are genetically engineered proteins that stimulate red blood cell production. This study investigates treatment of anemia using either epoetin alfa or darbepoetin alfa during chemotherapy in adult patients with cancer. The study is intended to collect information on normal medical practice and routine anemia management performed at the participating centers. This is an observational, non-randomized, prospective, comparative, parallel-group survey performed in The Netherlands. Patients with various severities of disease may enter the survey as soon as either their epoetin alfa or their darbepoetin alfa treatment starts and will be followed until the end of their epoetin alfa/darbepoetin alfa treatment. Patient data are collected, on average, once monthly (depending on the treatment being received) and this continues until 4 weeks after the end of treatment with epoetin alfa or darbepoetin alfa. An assessment of cost-effectiveness will be made for both treatments. The assessment of cost-effectiveness will be based on the following: cancer type and status, chemotherapy and other anti-cancer treatment, hemoglobin levels, use of either epoetin alfa or darbepoetin alfa, use of blood transfusions, and serum iron levels and iron supplementation. Safety evaluations include the incidence of serious and non-serious adverse events. Because the study involves only collection of information, no treatment will be required by the Sponsor and no medication will be supplied by the Sponsor. Epoetin alpha and darbepoetin alpha are administered according to routine clinical practice.

Study Type

Observational

Enrollment (Actual)

492

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • 'S-Hertogenbosch, Netherlands
      • Amstelveen, Netherlands
      • Amsterdam, Netherlands
      • Bergen Op Zoom, Netherlands
      • Den Helder, Netherlands
      • Dirksland, Netherlands
      • Ede Gld, Netherlands
      • Eindhoven, Netherlands
      • Goes, Netherlands
      • Gorinchem, Netherlands
      • Helmond, Netherlands
      • Hoofddorp, Netherlands
      • Meppel, Netherlands
      • Purmerend, Netherlands
      • Rotterdam, Netherlands
      • Spijkenisse, Netherlands
      • Tilburg, Netherlands
      • Utrecht, Netherlands
      • Winterswijk, Netherlands
      • Zeist, Netherlands

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-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.

Description

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • Patients not meeting all of the inclusion criteria for entry into the study
  • Patients who cannot read the Dutch language and/or do not understand the Dutch Informed Consent Form

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
1
Epoetin alfa 40 000 IU once weekly variable treatment length.
40,000 IU once weekly, variable treatment length.
2
Darbepoetin alfa Either 150 ug once weekly or 500 ug once every 3 wks variable treatment length.
Either 150 ug once weekly or 500 ug once every 3 wks, variable treatment length.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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.
Time Frame: 4 weeks, 8 weeks and end of treatment
4 weeks, 8 weeks and end of treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
Safety evaluations including the incidence of serious and non-serious adverse events.
Time Frame: from start of (Darb)epoetin treatment to end of study.
from start of (Darb)epoetin treatment to end of study.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2005

Primary Completion (Actual)

February 1, 2011

Study Completion (Actual)

February 1, 2011

Study Registration Dates

First Submitted

December 9, 2005

First Submitted That Met QC Criteria

December 9, 2005

First Posted (Estimate)

December 12, 2005

Study Record Updates

Last Update Posted (Estimate)

May 7, 2014

Last Update Submitted That Met QC Criteria

May 6, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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