Epoetin Beta in Patients Undergoing Chemotherapy for Solid Tumors
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|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)
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
|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|