Epoetin Beta in Patients Undergoing Chemotherapy for Solid Tumors
Recruitment status was: Recruiting
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.
Unspecified Adult Solid Tumor, Protocol Specific
Biological: epoetin beta
Drug: systemic chemotherapy
Procedure: quality-of-life assessment
|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|
- Treatment failure (changes in hemoglobin levels) [ Designated as safety issue: No ]
|Study Start Date:||December 2007|
|Estimated Primary Completion Date:||November 2009 (Final data collection date for primary outcome measure)|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00875004
|Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle|
|Montpellier, France, 34298|
|Principal Investigator:||Damien Pouessel, MD||Institut du Cancer de Montpellier - Val d'Aurelle|