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Survey on the Treatment of Anemia Using Recombinant Human Erythropoietin 2 (STAR-2)

NCT ID: NCT00398749

Last Updated: 2012-11-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1927 participants

Study Classification

OBSERVATIONAL

Study Start Date

2005-10-31

Study Completion Date

2009-11-30

Brief Summary

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The main purpose of this study is to evaluate the safety and efficacy (% response) of epoetin alfa in the treatment of anemia in adults receiving chemotherapy for cancer.

Detailed Description

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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, used to treat anemia in cancer patients, is a genetically engineered protein that stimulates red blood cell production. This study investigates treatment of anemia using epoetin 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 their epoetin alfa treatment starts and will be followed until the end of their epoetin alfa treatment. Patient data are collected in Case Report Forms (CRFs) until 4 weeks after the end of treatment with epoetin alfa. At the end of treatment completed CRFs will be collected. The assessment of effectiveness/response will be based on the following: cancer type and status, chemotherapy and other anti-cancer treatment, hemoglobin levels, 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 is observational, dosage, administration and duration of treatment is at discretion of treating physician.

Conditions

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Anemia Neoplasms

Keywords

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Anemia Neoplasms Antineoplastic agents Chemotherapy Efficacy Epoetin alfa

Study Design

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Study Time Perspective

PROSPECTIVE

Study Groups

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Epoetin alfa

Epoetin alfa 40 000 IU once weekly variable treatment length

Epoetin alfa

Intervention Type DRUG

40,000 IU once weekly, variable treatment length

Interventions

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Epoetin alfa

40,000 IU once weekly, variable treatment length

Intervention Type DRUG

Eligibility Criteria

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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 epoetin alfa treatment (expected treatment duration is at least 4 weeks)

Exclusion Criteria

* Patients who cannot read the Dutch language and/or do not understand the Dutch Informed Consent Form and patients participating in either of our observational studies, EVALUATE or COMPARE
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Janssen-Cilag B.V.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Janssen-Cilag B.V. Clinical Trial

Role: STUDY_DIRECTOR

Janssen-Cilag B.V.

Countries

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Netherlands

Related Links

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http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_JNJ_6051&studyid=270&filename=CR005596_CSR.pdf

Survey on the Treatment of Anemia Using Recombinant Human Erythropoietin 2 (STAR-2)

Other Identifiers

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EPOCAN4018

Identifier Type: -

Identifier Source: secondary_id

CR005596

Identifier Type: -

Identifier Source: org_study_id