- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00264108
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
Intervention / Treatment
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.
Sponsor
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- CR002455
- EPOCAN4015
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.
Clinical Trials on Neoplasms
-
European Association for Endoscopic SurgeryWithdrawn
-
Moscow Clinical Scientific CenterRecruitingCecal Neoplasms | Colonic Neoplasms MalignantRussian Federation
-
Chang Gung Memorial HospitalNational Science and Technology CouncilNot yet recruiting
-
Instituto Nacional de Cancer, BrazilCompletedHead Neck NeoplasmsBrazil
-
Sun Yat-sen UniversityPeking Union Medical College Hospital; RenJi Hospital; Shengjing Hospital; First... and other collaboratorsRecruitingSurgery | Rectal Neoplasms MalignantChina
-
NovartisBayerCompletedColorectal Neoplasms | Rectal Neoplasms | Colonic NeoplasmsBelgium, Germany, Italy, United States, Taiwan, Switzerland, Spain, Canada, Slovakia, United Kingdom, New Zealand, Australia, Portugal, Brazil, Hungary, Czechia, France, Netherlands, Sweden
-
Attikon HospitalCompleted
-
Wyeth is now a wholly owned subsidiary of PfizerCompletedColorectal Neoplasms | Rectal Neoplasms | Colonic Neoplasms
-
Cancer Institute and Hospital, Chinese Academy...Unknown
-
John M. BuattiNational Cancer Institute (NCI); National Institutes of Health (NIH)CompletedUterine Cervical Neoplasms | Prostatic Neoplasms | Rectal Neoplasms | Endometrial Neoplasms | Anus NeoplasmsUnited States
Clinical Trials on Epoetin alfa
-
Hospital de Clinicas de Porto AlegreOswaldo Cruz Foundation; Rio Grande do Sul State Health Department - SES/RSCompletedComparison of the Efficacy of Two Formulations of Epoetin in Patients Undergoing Hemodialysis
-
M.D. Anderson Cancer CenterCompleted
-
Johnson & Johnson Pharmaceutical Research & Development...Ortho Biotech, Inc.Completed
-
Johnson & Johnson Pharmaceutical Research & Development...Ortho Biotech Products, L.P.CompletedKidney Diseases | Anemia
-
Johnson & Johnson Pharmaceutical Research & Development...CompletedBlood Transfusion | Orthopedic Surgery | Orthopedic Procedures | Mammaplasty | Cardiovascular Surgical Procedures | Blood Transfusion, Autologous
-
Johnson & Johnson Pharmaceutical Research & Development...Ortho Biotech Products, L.P.Terminated
-
Johnson & Johnson Pharmaceutical Research & Development...Completed
-
Johnson & Johnson Pharmaceutical Research & Development...Ortho Biotech Products, L.P.CompletedCritical Illness | Anemia
-
Johnson & Johnson Pharmaceutical Research & Development...Completed
-
Johnson & Johnson Pharmaceutical Research & Development...Centocor Ortho Biotech Services, L.L.C.Completed