Epoetin Beta in Patients Undergoing Chemotherapy for Solid Tumors
|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
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|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||300 participants|
|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|
- Treatment failure (changes in hemoglobin levels)
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00875004
|Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle||Recruiting|
|Montpellier, France, 34298|
|Contact: Damien Pouessel, MD 33-4-6761-3545|
|Principal Investigator:||Damien Pouessel, MD||Institut du Cancer de Montpellier - Val d'Aurelle|