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A Study of the Safety and Effectiveness of Epoetin Alfa on Hemoglobin Levels and Blood Transfusions in Cancer Patients Receiving Chemotherapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00216541
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : May 19, 2011
Sponsor:
Information provided by:
Janssen-Cilag B.V.

Tracking Information
First Submitted Date  ICMJE September 13, 2005
First Posted Date  ICMJE September 22, 2005
Last Update Posted Date May 19, 2011
Study Start Date  ICMJE August 2003
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: September 13, 2005)
Change in hemoglobin from the start of the study to 3 or 4, 8 or 9, and 12 weeks, and at the end of the treatment period
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 13, 2005)
Number of patients who receive an allogenic blood transfusion during the study
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of the Safety and Effectiveness of Epoetin Alfa on Hemoglobin Levels and Blood Transfusions in Cancer Patients Receiving Chemotherapy
Official Title  ICMJE Randomised Study to Evaluate the Effect of Early Intervention to Treat Anemia With Epoetin Alfa Versus Standard Use on Hemoglobin Levels and the Incidence of Blood Transfusions in Cancer Patients Receiving Chemotherapy
Brief Summary The purpose of this study is to evaluate the effect of early treatment with epoetin alfa in addition to best standard of care on hemoglobin levels and the need for red blood cell transfusions in cancer patients receiving chemotherapy as compared to patients receiving standard epoetin alfa treatment and best standard of care.
Detailed Description Cancer patients often experience anemia due to the disease itself, chemotherapy, or both. Quality of life is also affected, due in part to the tiredness associated with anemia. Previous studies with epoetin alfa have suggested that early intervention with epoetin alfa results in higher hemoglobin levels and lower incidence of red blood cell transfusions than are achieved with delayed intervention. This is a randomized, open-label, explorative, sequential study that evaluates the effects of early treatment with epoetin alfa to determine its impact on hemoglobin values and the need for red blood cell transfusions as well as the safety of epoetin alfa when used in the prevention of anemia during chemotherapy in adult patients with cancer. During their current course of chemotherapy, patients will receive either early treatment with epoetin alfa or standard treatment with epoetin alfa (epoetin alfa administered when hemoglobin is <=10 g/dL), in addition to best standard care. Best standard care during chemotherapy may include red blood cell transfusions, white cell growth factors, folic acid, and iron supplementation, as needed. Effectiveness will be determined by the number of patients who receive an allogenic blood transfusion during the study and the change in hemoglobin at 3 or 4 weeks, 8 or 9 weeks, and 12 weeks, and at the end of the treatment period. Safety evaluations (incidence of adverse events, abnormal clinical laboratory tests, and vital signs) will be performed throughout the study. The study hypothesis is that cancer patients receiving chemotherapy who receive early treatment with epoetin alfa will have higher hemoglobin levels and fewer red blood cell transfusions than cancer patients receiving chemotherapy who receive standard treatment with epoetin alfa. This study will be conducted in the Netherlands and will only enroll European patients and will be generally well-tolerated. Epoetin alfa injections (40,000 units) under skin once a week either within 7 days after start of first chemotherapy cycle or from day hemoglobin is <=10 g/dL. Patients will receive epoetin alfa during the current course of chemotherapy or up to 24 weeks. Dose may be adjusted.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Anemia
  • Neoplasms
Intervention  ICMJE Drug: epoetin alfa
Study Arms  ICMJE Not Provided
Publications * Schouwink JH, Codrington H, Sleeboom HP, Kerkhofs LG, Wormhoudt LW. Prevention of anaemia by early intervention with once weekly epoetin alfa during chemotherapy. Eur J Cancer. 2008 Apr;44(6):819-29. doi: 10.1016/j.ejca.2008.02.017. Epub 2008 Mar 17.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 24, 2010)
110
Original Enrollment  ICMJE
 (submitted: September 13, 2005)
133
Actual Study Completion Date  ICMJE September 2006
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Confirmed diagnosis of cancer and planned to receive chemotherapy in 1, 2, 3, or 4 weekly schedules for a minimum of 8 weeks
  • have a hemoglobin level of >10 grams per deciliter and <= 12 grams per deciliter within 14 days before the start of the first on-study chemotherapy cycle
  • Eastern Cooperative Oncology Group (scale used by researchers to represent the level of activity a patient is capable of) score of 0 (able to carry out all normal activity without restriction) to 2 (ambulatory and capable of all self-care but unable to carry out any work)
  • life expectancy of >=6 months
  • female subjects postmenopausal for at least 1 year, surgically sterile or practicing an effective method of birth control

Exclusion Criteria:

  • Clinically significant or uncontrolled disease/dysfunction of any body system that is not due to cancer or chemotherapy, including uncontrolled or severe cardiovascular disease, recent (< 6 months) myocardial infarction, uncontrolled high blood pressure, congestive heart failure, or uncontrolled or unexplained history of seizures
  • planned surgery expected to influence hemoglobin levels, within the first 8 or 9 weeks of study entry
  • major illness or infection within 1 month of study entry
  • highly increased risk of thrombotic or other vascular events
  • androgen therapy within 2 months of study entry
  • anemia due to factors other than cancer/chemotherapy (e.g., severe hemolysis, gastrointestinal bleeding, or myelodysplastic syndromes)
  • blood transfusion within 14 days prior to study entry
  • pregnant or lactating females
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries Netherlands
 
Administrative Information
NCT Number  ICMJE NCT00216541
Other Study ID Numbers  ICMJE CR003541
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Janssen-Cilag B.V.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Janssen-Cilag B.V. Clinical Trial Janssen-Cilag B.V.
PRS Account Janssen-Cilag B.V.
Verification Date June 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP