The prevention of acute or delayed Chemotherapy-Induced Nausea and Vomiting (CINV) by the combination of palonosetron 250 microgrammes and methylprednisolone 80 mg in patients receiving a first administration of a first line of emetogenic chemotherapy to treat their non metastatic breast cancer. MedDRA version: 8.1 Level: LLT Classification code 10056989 Term: Nausea post chemotherapy
Conditions
Interventions
Trade Name: ALOXI
Pharmaceutical Form: Solution for injection
INN or Proposed INN: palonosetron
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 250-
Trade Name: SO
Sponsors
THERABEL LUCIEN PHARMA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Age > 18 years - Female - Patients with non-metastatic breast cancer (cytologically or histologically confirmed) and who are to receive a 1st course of adjuvant chemotherapy on D1 - Patients must receive one of the three following chemotherapy regimens, all of those being fully administrated at Day 1 (D1) every 3 (or 4) weeks (there shall not be any chemotherapy administration in the meantime between V1 and V2): a) 5-FU (500 mg/m2) + Epirubicin (75 or 100 mg/m2) + Cyclophosphamide (500 mg/m² ): FEC (75 or 100) b) Epirubicin (75 mg/m²) + Cyclophosphamide (> 500 mg/m²): EC c) Adriamycin (40 or 50 mg/m²) + Cyclophosphamide (> 500 mg/m²): AC - Patients who have given their informed consent in writing - Karnofsky performance status > 60 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Pregnant or breastfeeding female - Vomiting events (or retching) or nausea on the day of inclusion or in the 24 hours preceding the day of inclusion - Female suffering from alcoholism or drug dependency - Patients included in a clinical trial in the previous month - Patients whose language ability or ability to understand could negatively affect the proper completion of the self-evaluation diary. - Prior treatment with palonosetron - Contraindication to methylprednisolone (SPC of SOLUMEDROL®, Appendices § 14.7) - An ongoing cancer chemotherapy other than that which is allowed in the inclusion criteria of the protocol - Administration in the 24 hours prior to inclusion or on the day of the inclusion of any of the following medicinal products: a) Other ‘setrons’ (ondansetron, granisetron, tropisetron, dolasetron) b) Metoclopramide, phenothiazine (perphenazine), scopolamine, diphenhydramine, chlorphenamine, benzodiazepines (except for temazepam or triazolam used as a single dose as a hypnotic), haloperidol, droperidol, tetrahydrocannabinol c) Corticosteroid therapy (except for topical and inhaled preparations, which are allowed) - Hypersensitivity to the active substance or any of the excipients
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: to evaluate the therapeutic activity of palonosetron given as a single 250 micrograms IV administration, in combination with 80 mg of methylprednisolone given intravenously, in the prevention of acute or delayed nausea and vomiting episodes in “naïve” patients who are receiving a first cycle of a first line of emetogenic chemotherapy for their non metastatic breast cancer.;Secondary Objective: to study the tolerability of palonosetron used in combination with methylprednisolone in these patients.;Primary end point(s): The primary endpoint is the evaluation of nausea and vomiting using the self-evaluation diary filled out by the patient: - Acute CINV (Chemotherapy-Induced Nausea and Vomiting) (first 24 hours) - Delayed CINV (D2, D3, D4 and D5). The primary evaluation measure is the percentage of complete responses, defined by the percentage of patients who have: - Not experienced an emetic episode - And who have not received antiemetic rescue medication (at investigator’s discretion). An emetic episode is defined as: - A single vomiting event - A sequence of vomiting events separated by less than one minute - Any number of unproductive retching events lasting more than 5 minutes - Any number of unproductive retching events lasting less than 5 minutes and vomiting separated by less than one minute. | — |
Countries
France
Outcome results
None listed