Clinical trial NCT00875004: Epoetin Beta in Patients Undergoing Chemotherapy for Solid Tumors
Official title: Research Factors Predictive of Treatment Failure With Erythropoietin Beta (NeoRecormon®) in Patients With Solid Tumors Treated With Chemotherapy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Anemia
Unspecified Adult Solid Tumor, Protocol Specific
Keywords: anemia
unspecified adult solid tumor, protocol specific
Lead sponsor: Institut du Cancer de Montpellier - Val d'Aurelle
Sponsor class: OTHER
First posted: 2009-04-03
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Treatment failure (changes in hemoglobin levels)
timeFrame: From date of randomization until the week 8
Secondary outcomes:
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
Study officials:
affiliation: Institut du Cancer de Montpellier - Val d'Aurelle
name: Damien Pouessel, MD
role: PRINCIPAL_INVESTIGATOR
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