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

NCT ID: NCT00264108

Last Updated: 2014-05-07

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 492 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2005-06-30
• Study Completion Date: 2011-02-28

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.

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.

Conditions

Anemia; Neoplasms

Study Design

• Study Time Perspective: PROSPECTIVE

Study Groups

1

Epoetin alfa 40 000 IU once weekly variable treatment length.

Epoetin alfa

Intervention Type: DRUG

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.

Darbepoetin alfa

Intervention Type: DRUG

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

Interventions

Darbepoetin alfa

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

Intervention Type: DRUG

Epoetin alfa

40,000 IU once weekly, variable treatment length.

Intervention Type: DRUG

Eligibility 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)

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Janssen-Cilag B.V.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen-Cilag B.V. Clinical Trial

Role: STUDY_DIRECTOR

Janssen-Cilag B.V.

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

Countries

Netherlands

Other Identifiers

EPOCAN4015

Identifier Type: -

Identifier Source: secondary_id

CR002455

Identifier Type: -

Identifier Source: org_study_id