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

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.

Inclusion criteria :

• Age > 18 years
• Hemoglobin levels between [ > 9g/dl - < 11 g/dl ] .
• Patient requiring erythropoietine beta treatment for a foreseeable duration of at least 8 weeks under the same chemotherapy protocol.
• Patient with cancer undergoing chemotherapy
• Patient without EPO within 6 months prior to current chemotherapy.
• WHO 2 performance status (Appendix 1).
• Patient information and signature of informed consent or legal representative

Exclusion criteria :

• Hemoglobin < 9 g/dl or > 11 g/dl
• Patient with cancer not treated with chemotherapy (targeted therapy, hormone therapy, etc…)
• Patient with cancer treated with concomitant radiation chemotherapy.
• Co-treated with Epo beta and scheduled transfusion prior to inclusion.
• Hypersensitivity to the active substance or one of the NeoRecormon excipients®
• Poorly controlled high blood pressure
• Pregnant woman, likely to be pregnant or breastfeeding,
• Persons deprived of liberty or under guardianship,
• Unable to undergo medical follow-up for geographic, social or psychological reasons.