Anemia, Unspecified Adult Solid Tumor, Protocol Specific
Conditions
Keywords
anemia, unspecified adult solid tumor, protocol specific
Brief 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.
Interventions
BIOLOGICALepoetin beta
DRUGsystemic chemotherapy
PROCEDUREquality-of-life assessment
Sponsors
Institut du Cancer de Montpellier - Val d'Aurelle
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 120 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Treatment failure (changes in hemoglobin levels) | From date of randomization until the week 8 | The 8th week of treatment assessment defines the patient on erythropoeitine beta (NeoRecormon®) treatment for failure or success |
Countries
France
Outcome results
None listed