Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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.
 
ClinicalTrials.gov 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
Sponsor:
Information provided by:
National Cancer Institute (NCI)

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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:

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.


Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
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

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 ClinicalTrials.gov identifier (NCT number): NCT00875004


Locations
Layout table for location information
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
Institut du Cancer de Montpellier - Val d'Aurelle
Investigators
Layout table for investigator information
Principal Investigator: Damien Pouessel, MD Institut du Cancer de Montpellier - Val d'Aurelle
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for additonal information
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
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):
anemia
unspecified adult solid tumor, protocol specific
Additional relevant MeSH terms:
Layout table for MeSH terms
Anemia
Neoplasms
Hematologic Diseases
Epoetin Alfa
Hematinics