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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Janssen-Cilag B.V.
ClinicalTrials.gov Identifier:
NCT00264108
First received: December 9, 2005
Last updated: May 6, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention Phase
Anemia
Neoplasms
Drug: Darbepoetin alfa
Drug: Epoetin alfa
Phase 4

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: EPREX (Epoetin Alfa) Versus ARANESP (Darbepoetin Alfa): Looking at Outcome of Anemia Treatment and Comparing Cost-effectiveness (EVALUATE).

Resource links provided by NLM:


Further study details as provided by Janssen-Cilag B.V.:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety evaluations including the incidence of serious and non-serious adverse events. [ Time Frame: from start of (Darb)epoetin treatment to end of study. ] [ Designated as safety issue: No ]

Enrollment: 492
Study Start Date: June 2005
Study Completion Date: February 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1
Epoetin alfa 40 000 IU once weekly variable treatment length.
Drug: Epoetin alfa
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.
Drug: Darbepoetin alfa
Either 150 ug once weekly or 500 ug once every 3 wks, variable treatment length.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00264108

Locations
Netherlands
'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
Sponsors and Collaborators
Janssen-Cilag B.V.
Investigators
Study Director: Janssen-Cilag B.V. Clinical Trial Janssen-Cilag B.V.
  More Information

No publications provided

Responsible Party: Janssen-Cilag B.V.
ClinicalTrials.gov Identifier: NCT00264108     History of Changes
Other Study ID Numbers: CR002455, EPOCAN4015
Study First Received: December 9, 2005
Last Updated: May 6, 2014
Health Authority: Netherlands: Netherlands Medicines Evaluation Board

Keywords provided by Janssen-Cilag B.V.:
Antineoplastic agents
Chemotherapy
Cost-effectiveness
Epoetin alfa
Darbepoetin alfa

Additional relevant MeSH terms:
Anemia
Neoplasms
Hematologic Diseases
Antineoplastic Agents
Epoetin alfa
Darbepoetin alfa
Therapeutic Uses
Pharmacologic Actions
Hematinics
Hematologic Agents

ClinicalTrials.gov processed this record on August 26, 2014