Metastatic castration-resistant prostate cancer (mCRPC)
Conditions
Interventions
Trade Name: JEVTANA
Product Name: JEVTANA
Pharmaceutical Form: Concentrate and solvent for solution for infusion
CAS Number: 183133-96-2
Other descriptive name: CABAZITAXEL
Concentration unit: mg/ml m
Sponsors
A.R.T.I.C (Association pour la Recherche de Thérapeutiques Innovantes en Cancérologie)
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1.Patient aged = 65 years with mCRPC previously treated with docetaxel 2.Medical or surgical castration with castrate level of testosterone ( 14; or G8 score = 14 with geriatric assessment concluding to reversible impairment allowing use of chemotherapy 6.ECOG-PS 0, 1 or 2(ECOG-PS= 2 should be related to prostate cancer) 7.Adequate hematologic, liver and renal functions: a)Neutrophil count =1.5 109/L b)Haemoglobin =10 g/ dL c)Platelet count =100.109/L d)Total bilirubin = 1 the upper limit of normal (ULN) e)Transaminases = 1.5 ULN f)Serum creatinine = 2.0 ULN 8.Ongoing LHRH therapy at study entry 9.Signed informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) no 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 170
Exclusion criteria
Exclusion criteria: 1.History of severe hypersensitivity reaction (=grade 3) to docetaxel 2.History of severe hypersensitivity reaction (=grade 3) to polysorbate 80 containing drugs 3.Uncontrolled severe illness or medical condition (including uncontrolled diabetes mellitus) 4.Concurrent or planned treatment with strong inhibitors or strong inducers of cytochrome P450 3A4/5 (a one week wash-out period is necessary for patients who are already on these treatments) (see Appendix E) 5.ECOG-PS >2 not related to prostate cancer disease 6.G8 = 14 with geriatric assessment contra-indicating standard cabazitaxel regimen 7.Concomitant vaccination with yellow fever vaccine 8.Patient who cannot be regularly followed or cannot answer to quality of life questionnaires because of psychological, social, familial or geographic reasons. 9.Participation in another clinical trial with any investigational drug within 30 days prior to study enrolment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the incidence of grade = 3 neutropenia (measured at Day 7 and Day 14) and/or neutropenic complications (febrile neutropenia, neutropenic infection) with two schedules of cabazitaxel (bi-weekly versus tri-weekly) plus prednisone in elderly men (= 65 years) with mCRPC previously treated with a docetaxel-containing regimen.;Secondary Objective: The following parameters will be evaluated in each arm: •Dose reductions and dose delays •Radiological progression-free survival (rPFS) •Time to PSA progression •Time to first symptomatic Skeletal-Related Event (SRE) and incidence of SREs •Time to opioid treatment (if relevant) •Prostate-specific antigen (PSA) response rate •Quality of Life (FACT-P) •Objective response rate (ORR) in measurable lesions (RECIST criteria 1.1 ) •Overall Survival (OS) •Factors influencing survival (duration of response to first androgen deprivation therapy (ADT), serum testosterone, cumulative dose of cabazitaxel, neutrophils/lymphocytes ratio, Gleason score, geriatric assessment G8, grade =3 neutropenia). •Time to onset of grade =3 neutropenia •Grade =3 neutropenia duration ( from date of onset of grade = 3 until grade = 2) •Analysis of grade =3 neutropenia and/or neutropenia by cycle •Adverse events ;Primary end point(s): The primary end point is: •grade =3 neutropenia (measured at D7 and D14 of each cycle) and/or neutropenic complications (febrile neutropenia, neutropenic infection or sepsis) during the overall treatment period;Timepoint(s) of evaluation of this end point: Neutropenia will be measured at D7 and D14 of each cycle | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The secondary endpoints are: •Dose reductions and dose delays •Radiological progression-free survival (rPFS) •PSA response and time to PSA progression •Time to first symptomatic Skeletal-Related Event (SRE) and incidence of SREs •Time to opioid treatment (if relevant) •Quality of life (FACT-P) •Objective response rate (ORR) in measurable lesions (RECIST) •Overall Survival (OS) •Factors influencing survival (duration of response to first ADT, serum testosterone, cumulative dose of cabazitaxel, neutrophils/lymphocytes ratio, Gleason score, G8, grade =3 neutropenia) •Time to onset of grade =3 of neutropenia •Grade =3 neutropenia duration ( from date of onset of grade = 3 until grade = 2) Analysis of grade =3 neutropenia and/or neutropenia by cycle •Adverse events ;Timepoint(s) of evaluation of this end point: For the 2 arms (A and B): -tumor evaluation (CT-Scan abdominal/pelvic/chest or whole body MRI and Bone scan): every 3 months -PSA, FACT-P, pain status (VAS), SRE: at each visit -hematology: every week | — |
Countries
Germany, Netherlands
Contacts
Public ContactSponsor
A.R.T.I.C (Association pour la Recherche de Thérapeutiques Innovantes en Cancérologie)
Outcome results
None listed