Clinical trial NCT00398749: Survey on the Treatment of Anemia Using Recombinant Human Erythropoietin 2 (STAR-2)
Official title: Survey on the Treatment of Anemia Using Recombinant Human Erythropoietin 2
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anemia
Neoplasms
Keywords: Anemia
Neoplasms
Antineoplastic agents
Chemotherapy
Efficacy
Epoetin alfa
Lead sponsor: Janssen-Cilag B.V.
Sponsor class: INDUSTRY
First posted: 2006-11-14
Enrollment: 1927
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Cancer patients receiving epoetin alfa as anemia treatment during chemotherapy, as part of the common practice of participating physicians. Patients may enter the study as soon as their epoetin alfa treatment starts.

Brief 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.

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, 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.

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 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

Primary outcomes:
measure: 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
timeFrame: 4 weeks, 8 weeks and end of treatment
Secondary outcomes:
measure: Incidence of adverse events
timeFrame: from start epoetin treatment to end of study
Other outcomes:
Locations:
Study officials:
affiliation: Janssen-Cilag B.V.
name: Janssen-Cilag B.V. Clinical Trial
role: STUDY_DIRECTOR
References: