Epoetin Beta in Patients Undergoing Chemotherapy for Solid Tumors

Institut du Cancer de Montpellier - Val d'Aurelle27 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Anemia Unspecified Adult Solid Tumor, Protocol Specific

Interventions

epoetin betaBIOLOGICAL

systemic chemotherapyDRUG

quality-of-life assessmentPROCEDURE

Eligibility

Sex: ALLMin age: 18 YearsMax age: 120 Years

Medical Language ↔ Plain English

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.

Locations (1)

Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle

Montpellier, France

Outcomes

Primary Outcomes

Treatment failure (changes in hemoglobin levels)

The 8th week of treatment assessment defines the patient on erythropoeitine beta (NeoRecormon®) treatment for failure or success

Time frame: From date of randomization until the week 8

Data from ClinicalTrials.gov

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