hormone refractory prostate carcinoma MedDRA version: 6.1 Level: HLT Classification code 10036908
Conditions
Interventions
Trade Name: TAXOTERE*INFUS FL 20MG/0,5ML+F
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Docetaxel
CAS Number: 114977-28-5
Concentration unit: mg milligram(s)
Concentration type: equ
Sponsors
None listed
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: Histologically confirmed prostate adenocarcinoma foci of neuroendocrine differentiation are permitted Metastatic disease with documented clinical progression CT or bone scan, MRI and/or biochemical progression PSA increase refractory to hormone therapy. For those patients whose the sole evidence of progressione is the PSA raise, a minimum value of 20 ng/ml of PSA is requested for accrual Measurable disease one-dimension and/or non-measurable e.g. new lesions on bone scan . In case of sole clinical progression, patients must have at least one measurable lesione according to RECIST criteria Patients must have received a previous hormonal therapy defined as follows surgical castration or medical castration LHRH agonists with or without anti-androgens if the patient has been treated with LHRH analogues, these must be continued Evaluation of anti-androgen withdrawal syndrome if the patients has been treated with anti-androgens, these must have been withdrawn since 4 weeks, in case of flutamide or cyproterone acetate, or 6 weeks in case of bicalutamide; patients must show further progression, though the antiandrogen withdrawal, before entering the study Suppressed levels of testosterone T 8804; 50 ng/dl . Previous oral estramustine is permitted; however, this drug must have been withdrawn from at least 4 weeks, with complete recovery from its side-effects Previous radiotherapy is permitted, if completed from at least 4 weeks and covering 25 of bone marrow, with with complete recovery from its side-effects Previous surgery is permitted, even with palliative intent, if performed from at least 4 Life expectancy 3 months Age 18 and 80 years PS 8804; 2 ECOG Scale Neutrophils 8805; 1.500/L; Platelets 8805; 100.000/L; Hemoglobin 8805; 9 g/dl AST e ALT 8804;2.5 times upper normal limit; Bilirubin 8804;1.5 times upper normal limit; Creatinine 8804;1.5 times upper normal limit for creatinine values between 1.4 e 1.5 times, creatinine clearance will be calculated, and the clearance will have to be 8805;50ml/min Accessibility to therapy and follow up for patients Written informed consent 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: Central nervous system metastases Other tumors, except skin basalioma unless the patient is free of disease from 8805;5 years Severe respiratory or cardiovascular diseases congestive heart failure, positive history for acure myocardial infarction, angina pectoris, in the 6 moths preceding the study enter; non-controlled arrhythmias or hypertension Non-controlled diabetes mellitus , peptic ulcer, other contraindications to the use of corticosteroids Active infections Severe peripheral neuropathy 8805; grade 2 NCI-CTC . Severe neurological or psychiatric impairments Previous chemotherapy except estramustine, if withdrawn from at least 4 weeks before entering the study Concomitant treatment with other antineplastic drugs except LHRH analogue Accrual in other clinical trials with other experimental drugs in the 30 days preceding the inclusion in the study, or concomitant therapy with other experimental drugs Previous therapy with radioisotopes e.g strontium or samarium ; Systemic corticosteroid therapy for reason different from those specified in the protocol Hypersensitivity to Polysorbate 80
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: PHASE I to assess the tolerability of weekly docetaxel combined with daily oral low doses of prednisone and cyclophosphamide in patients with hormone-refractory prostate carcinoma PHASE II to evaluate the activity of such combination regarding the Overall Response Rate;Secondary Objective: to evaluate the activity of such combination with regard to PSA Biochemical Response Rate BRR, 50 decrease of PSA value , Time to Progression TTP , Time to Biochemical Progression TTPB to assess, through retrospective analysis, the possibility of predicting response to metronomic chemotherapy by basal dosing and subsequent monitoring of circulating levels of VEGF and CEC, in order to identify early markers of response to this approach.;Primary end point(s): response rate | — |
Countries
Italy
Outcome results
None listed