Epoetin Beta in Patients Undergoing Chemotherapy for Solid Tumors

Study Overview
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Brief Summary
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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
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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.

Official Title
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Research Factors Predictive of Treatment Failure With Erythropoietin Beta (NeoRecormon®) in Patients With Solid Tumors Treated With Chemotherapy

Conditions
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Anemia, Unspecified Adult Solid Tumor, Protocol Specific

Intervention / Treatment
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* Biological: epoetin beta
* Drug: systemic chemotherapy
* Procedure: quality-of-life assessment


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 120 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Erythropoietin beta<br> | Biological: epoetin beta<br> <br> Drug: systemic chemotherapy<br> <br> Procedure: quality-of-life assessment<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment failure (changes in hemoglobin levels) | The 8th week of treatment assessment defines the patient on erythropoeitine beta (NeoRecormon®) treatment for failure or success | From date of randomization until the week 8 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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anemia, unspecified adult solid tumor, protocol specific