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

Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00264108
• Other study ID #: CR002455
• Secondary ID: EPOCAN4015
• Status: Completed
• Phase: Phase 4
• First received: December 9, 2005
• Last updated: May 6, 2014
• Start date: June 2005
• Est. completion date: February 2011

Study information

• Verified date: May 2014
• Source: Janssen-Cilag B.V.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Netherlands Medicines Evaluation Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 492
• Est. completion date: February 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Anemia
• Neoplasms

Intervention

Drug:
• Darbepoetin alfa
Either 150 ug once weekly or 500 ug once every 3 wks, variable treatment length.
• Epoetin alfa
40,000 IU once weekly, variable treatment length.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Janssen-Cilag B.V.

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Safety evaluations including the incidence of serious and non-serious adverse events.		from start of (Darb)epoetin treatment to end of study.	No