NCT00875004

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: Institut du Cancer de Montpellier - Val d'Aurelle · Academic / Other
• Sex: All
• Age: 18 Years – 120 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Anemia
• Unspecified Adult Solid Tumor, Protocol Specific

Interventions

Type	Name	Description
BIOLOGICAL	epoetin beta
DRUG	systemic chemotherapy
PROCEDURE	quality-of-life assessment

Timeline

• Start date: 2007-12-07
• Primary completion: 2011-12-31
• Completion: 2011-12-31
• First posted: 2009-04-03
• Last updated: 2024-06-26

Locations

1 site across 1 country: France