ORMONO REFRACTORY CARCINOMA OF PROSTATE IN ADVANCED STAGE MedDRA version: 6.1 Level: PT Classification code 10007280
Conditions
Interventions
Pharmaceutical Form: Tablet
INN or Proposed INN: Celecoxib
CAS Number: 169590-42-5
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 200-
Pharmaceutical Form: Concen
Sponsors
AZIENDA USL 6 LIVORNO ZONA LIVORNESE
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: Patients with diagnosis of ormonorefrattario prostatico carcinoma in advanced phase - ECOG PS 2 - Attended of life at least 3 months - Adapted renal functionality creatinina 1,25 x V.N. - Adapted hepatic functionality bilirubina tot. 1,5 x V.N., SGOT and SGPT 3 xV.N., - Adapted reservoir medullary GB 3000/mcl, PLT 100.000/mcl, Hgb 10 g/dl. - informed Consent written - Suspension from at least 30 drug days antiandrogens with demonstration not answer of the PSA to the suspension 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
Exclusion criteria
Exclusion criteria: Scompensate metabolic diseases or serious infections in action - cardiac Arrhythmies or ischemic cardiopathy and presence of whichever elevated cardiovascular risk - Impossibility to execute adequate follow-up - Presence of sintomatic encefalic metastases - a Presence of second neoplasia. - gastroduodenal Presence of ulcera
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate antitumor activity like reduction of the value of PSA 50 as a result of the metronomic use of Ciclofosfamide CTX in association to Celecoxib and Desametasone DXM .;Secondary Objective: To evaluate antitumor activity like RO with criteria RECIST - To estimate the profile of toxicity of the association - To estimate the time to progression and the survival - To estimate the variations of the levels put molding on to us of the Tsp-1, the VEGF and the sVEGFR-2 to continuation of the metronomic treatment - To estimate the variations of the mRNA circulating of VE-caderina in the peripheral blood to continuation of the metronomic treatment - To estimate the variations in the expression and synthesis of Tsp-1 and VEGF in the mononucleate cells of the peripheral blood to continuation of the metronomic treatment - To estimate more you attend genetic polymorphisme of cytochromes CYP2B6, CYP2C19, CYP2C9 and CYP 5 in the mononucleate cells of the peripheral blood, correlating them with the observed antiangiogenic/antitumoral answer. - Quality of Life and control of the pain;Primary end point(s): The treatment will come continuativamente continued in case of clinical benefit or until progression of disease, unacceptable toxicity or refusal of the patient to continue. The patients will continue also the assumption of analogous Lh-rh quarterly salary or and of biphosphonates | — |
Countries
Italy
Outcome results
None listed