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Epoetin Beta in Patients Undergoing Chemotherapy for Solid Tumors

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2009 by National Cancer Institute (NCI).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00875004
First received: April 2, 2009
Last updated: December 13, 2009
Last verified: July 2009
History of Changes
  Purpose

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:

MedlinePlus related topics: Anemia Cancer
U.S. FDA Resources

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

Primary Outcome Measures:
  • Treatment failure (changes in hemoglobin levels) [ Designated as safety issue: No ]

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

OBJECTIVES:

Primary

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

Secondary

  • 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

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

PATIENT CHARACTERISTICS:

  • 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

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • More than 6 months since prior epoetin
  • No concurrent chemoradiotherapy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00875004

Locations
France
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
Centre Val d'Aurelle - Paul Lamarque
Investigators
Principal Investigator: Damien Pouessel, MD Centre Val d'Aurelle - Paul Lamarque
  More Information

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier: NCT00875004     History of Changes
Other Study ID Numbers: CDR0000633325, CLCC-PLATON, CLCC-VA-2007/21, CLCC-AFSSAPS-A70755-52, INCA-RECF0639, EUDRACT-2007-003615-31, ROCHE-CLCC-PLATON
Study First Received: April 2, 2009
Last Updated: December 13, 2009
Health Authority: Unspecified

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

Additional relevant MeSH terms:
Anemia
Neoplasms
Hematologic Diseases

ClinicalTrials.gov processed this record on May 23, 2013