Epoetin Beta in Patients Undergoing Chemotherapy for Solid Tumors (PLATON)

Institut du Cancer de Montpellier - Val d'Aurelle

Status

Terminated

Conditions

Anemia

Unspecified Adult Solid Tumor, Protocol Specific

Treatments

Procedure: quality-of-life assessment

Drug: systemic chemotherapy

Biological: epoetin beta

Study type

Interventional

Funder types

Other

Identifiers

NCT00875004

CLCC-AFSSAPS-A70755-52

CLCC-VA-2007/21

EUDRACT-2007-003615-31

CDR0000633325

ROCHE-CLCC-PLATON

INCA-RECF0639

Details and patient eligibility

About

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.

Full 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.

Enrollment

27 patients

Sex

All

Ages

18 to 120 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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.