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Epoetin Beta in Patients Undergoing Chemotherapy for Solid Tumors

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2009 by National Cancer Institute (NCI).
Recruitment status was:  Recruiting
Information provided by:
National Cancer Institute (NCI) Identifier:
First received: April 2, 2009
Last updated: December 13, 2009
Last verified: July 2009

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 Intervention
Anemia Unspecified Adult Solid Tumor, Protocol Specific Biological: epoetin beta Drug: systemic chemotherapy Procedure: quality-of-life assessment

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by National Cancer Institute (NCI):

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

Estimated Enrollment: 300
Study Start Date: December 2007
Estimated Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00875004

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
Principal Investigator: Damien Pouessel, MD Institut du Cancer de Montpellier - Val d'Aurelle
  More Information Identifier: NCT00875004     History of Changes
Other Study ID Numbers: CDR0000633325
Study First Received: April 2, 2009
Last Updated: December 13, 2009

Keywords provided by National Cancer Institute (NCI):
unspecified adult solid tumor, protocol specific

Additional relevant MeSH terms:
Epoetin Alfa
Hematinics processed this record on September 21, 2017