Patients with advanced metastatic prostatic carcinoma MedDRA version: 9.1 Level: LLT Classification code 10036909
Conditions
Interventions
Trade Name: NAVELBINE
Pharmaceutical Form: Capsule, soft
INN or Proposed INN: Vinorelbine
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 20-
Trade Name: SOLDESAM
Sponsors
ARCO
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: - Diagnosis of metastatic or locally advanced castration-resistant prostate adenocarcinoma, - Failure of previous docetaxel-based chemotherapy or patient unable to receive chemotherapy with docetaxel - Increasing PSA serum levels in three consecutive measuraments at least 1 week apart - PSA serum value ≥ 2 ng/mL - Serum Testosterone 3000/ mL, platelets > 100000/mL, haemoglobin level > 10 g/dL) - Interruption of antiandrogen therapy at least 4-8 weeks before enrollment, without biochemical response at time of suspension, in the absence of clinical or instrumental evidence of disease progression - Written informed consent Are the trial subjects under 18? yes 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: - Uncontrolled metabolic diseases or active infections - One of the following condition in the 12 months before the enrollment: - Miocardial infarction - Severe or unstable angina - Congestive heart failure - Pulmonary embolism, stroke, transient ischemic attack - Cardiac arrhythmias - QT interval > 450 msec - Coronary or periferic arterial bypass - Uncontrolledi hyperthension - Anticoaugulant treatment - Brain metastases - Second malignancies, except skin basal cell carcinoma
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: - To evaluate the percentage of patients free of progression (biochemical and/or instrumental) after 12 weeks of treatment with metronomic Vinorelbine and Dexamethasone;Secondary Objective: - To evaluate the variations of serum PSA levels from baseline after 12 weeks of treatment - To evaluate the antitumor activity in terms of objective response rate, according to modified RECIST criteria (PCWG2, Scher et al JCO 2008) - To evaluate the antitumor activity on bone metastases according to PCWG2 criteria (Scher et al JCO 2008) - To evaluate the toxicity profile of the treatment - To evaluate the time to biochemical and objective progression (PFS) - To evaluate the overall survival (OS) - To evaluate the quality of life (QoL) and pain control - To evaluate the Pharmacokinetic profile of Vinorelbine and its metabolite, 4-0-deacetil-Vinorelbine, during metronomic treatment - To evaluate the variations of plasma VEGF, TSP-1 and VEGFR-2 levels during treatment;Primary end point(s): - To evaluate the percentage of patients free of progression (biochemical and/or instrumental) after 12 weeks of treatment with metronomic Vinorelbine and Dexamethasone | — |
Countries
Italy
Outcome results
None listed