Study pilot of metronomic chemotherapy with ciclofosfamide, celecoxib and desametasone in patients with diagnosis of carcinoma of the refractory ormon prostate in advanced stage appraisal pharmacodynamics - PROMET
- Conditions
- ORMONO REFRACTORY CARCINOMA OF PROSTATE IN ADVANCED STAGEMedDRA version: 6.1Level: PTClassification code 10007280
- Registration Number
- EUCTR2005-005967-27-IT
- Lead Sponsor
- AZIENDA USL 6 LIVORNO ZONA LIVORNESE
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Male
- Target Recruitment
- 27
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
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method