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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.
Age
18 - 120 years
Sex
ALL
Healthy Volunteers
No
Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
Montpellier, France
Start Date
December 7, 2007
Primary Completion Date
December 31, 2011
Completion Date
December 31, 2011
Last Updated
June 26, 2024
27
ACTUAL participants
epoetin beta
BIOLOGICAL
systemic chemotherapy
DRUG
quality-of-life assessment
PROCEDURE
Lead Sponsor
Institut du Cancer de Montpellier - Val d'Aurelle
NCT05012111
NCT03520647
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