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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
Sponsor:
ClinicalTrials.gov Identifier:
NCT00875004
First Posted: April 3, 2009
Last Update Posted: December 15, 2009
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.
Information provided by:
National Cancer Institute (NCI)
April 2, 2009
April 3, 2009
December 15, 2009
December 2007
November 2009   (Final data collection date for primary outcome measure)
Treatment failure (changes in hemoglobin levels)
Same as current
Complete list of historical versions of study NCT00875004 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Epoetin Beta in Patients Undergoing Chemotherapy for Solid Tumors
Research Factors Predictive of Treatment Failure With Erythropoietin Beta (NeoRecormon®) in Patients With Solid Tumors Treated With Chemotherapy

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.

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.

Interventional
Not Provided
Allocation: Non-Randomized
Primary Purpose: Supportive Care
  • Anemia
  • Unspecified Adult Solid Tumor, Protocol Specific
  • Biological: epoetin beta
  • Drug: systemic chemotherapy
  • Procedure: quality-of-life assessment
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
300
Not Provided
November 2009   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
France
 
 
NCT00875004
CDR0000633325
CLCC-PLATON
CLCC-VA-2007/21
CLCC-AFSSAPS-A70755-52
INCA-RECF0639
EUDRACT-2007-003615-31
ROCHE-CLCC-PLATON
Not Provided
Not Provided
Not Provided
Not Provided
Institut du Cancer de Montpellier - Val d'Aurelle
Not Provided
Principal Investigator: Damien Pouessel, MD Institut du Cancer de Montpellier - Val d'Aurelle
National Cancer Institute (NCI)
July 2009

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