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Epoetin Beta in Patients Undergoing Chemotherapy for Solid Tumors

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. Identifier: NCT00875004
Recruitment Status : Unknown
Verified July 2009 by National Cancer Institute (NCI).
Recruitment status was:  Recruiting
First Posted : April 3, 2009
Last Update Posted : December 15, 2009
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

RATIONALE: Epoetin beta may cause the body to make more red blood cells and may prevent or reduce side effects in patients undergoing chemotherapy for solid tumors.

PURPOSE: This clinical trial is studying how well epoetin beta works in patients undergoing chemotherapy for solid tumors.

Condition or disease Intervention/treatment Phase
Anemia Unspecified Adult Solid Tumor, Protocol Specific Biological: epoetin beta Drug: systemic chemotherapy Procedure: quality-of-life assessment Not Applicable

Detailed Description:



  • Identify factors predictive of treatment failure in patients with solid tumors treated with epoetin beta while undergoing chemotherapy.


  • Evaluate the impact of achieving target hemoglobin levels (i.e., hemoglobin > 11 g/dL) after 8 weeks of treatment with epoetin beta.
  • Evaluate changes in hemoglobin levels from baseline to after 8 weeks of treatment with epoetin beta.
  • Evaluate the tolerability of epoetin beta in these patients.
  • Evaluate the quality of life of these patients.

OUTLINE: This is a multicenter study.

Patients receive epoetin beta subcutaneously once a week for ≥ 8 weeks in the absence of disease progression or unacceptable toxicity.

Patients complete a quality-of-life questionnaire (FACT-An) at baseline and after 8 weeks of treatment.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Non-Randomized
Primary Purpose: Supportive Care
Official Title: Research Factors Predictive of Treatment Failure With Erythropoietin Beta (NeoRecormon®) in Patients With Solid Tumors Treated With Chemotherapy
Study Start Date : December 2007
Estimated Primary Completion Date : November 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anemia

Primary Outcome Measures :
  1. Treatment failure (changes in hemoglobin levels)

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Diagnosis of solid tumor
  • Hemoglobin 9-11 g/dL
  • Planning to receive epoetin beta for ≥ 8 weeks while undergoing chemotherapy for cancer


  • WHO performance status 0-2
  • Not pregnant or nursing
  • Not incarcerated or under guardianship
  • No psychological, familial, social, or geographical reason that would preclude study follow-up


  • See Disease Characteristics
  • More than 6 months since prior epoetin
  • No concurrent chemoradiotherapy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00875004

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Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle Recruiting
Montpellier, France, 34298
Contact: Damien Pouessel, MD    33-4-6761-3545      
Sponsors and Collaborators
Institut du Cancer de Montpellier - Val d'Aurelle
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Principal Investigator: Damien Pouessel, MD Institut du Cancer de Montpellier - Val d'Aurelle

Layout table for additonal information Identifier: NCT00875004     History of Changes
Other Study ID Numbers: CDR0000633325
First Posted: April 3, 2009    Key Record Dates
Last Update Posted: December 15, 2009
Last Verified: July 2009
Keywords provided by National Cancer Institute (NCI):
unspecified adult solid tumor, protocol specific
Additional relevant MeSH terms:
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Hematologic Diseases
Epoetin Alfa