Status:
TERMINATED
Epoetin Beta in Patients Undergoing Chemotherapy for Solid Tumors
Lead Sponsor:
Institut du Cancer de Montpellier - Val d'Aurelle
Conditions:
Anemia
Unspecified Adult Solid Tumor, Protocol Specific
Eligibility:
All Genders
18-120 years
Phase:
NA
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 st...
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 ach...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
December 7 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2011
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT00875004
Start Date
December 7 2007
End Date
December 31 2011
Last Update
June 26 2024
Active Locations (1)
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1
Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
Montpellier, France, 34298