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

Neoplasms Clinical Trial

Official title:

Survey on the Treatment of Anemia Using Recombinant Human Erythropoietin 2

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00398749
• Other study ID #: CR005596
• Secondary ID: EPOCAN4018
• Status: Completed
• Phase: Phase 4
• First received: November 10, 2006
• Last updated: November 5, 2012
• Start date: October 2005
• Est. completion date: November 2009

Study information

• Verified date: November 2012
• Source: Janssen-Cilag B.V.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Independent Ethics Committee
• Study type: Observational

Clinical Trial Summary

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.

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, 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1927
• Est. completion date: November 2009
• Est. primary completion date: November 2009
• 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 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

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Anemia
• Neoplasms

Intervention

Drug:
• 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.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The assessment of effectiveness based on: epoetin alfa treatment schedule (dose and timing), hemoglobin effect, response to treatment (independent of blood transfusion), mean time to response, # of blood transfusions given, and iron supplementation		4 weeks, 8 weeks and end of treatment	No
Secondary	Incidence of adverse events		from start epoetin treatment to end of study	No

External Links

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