castration resistant prostate cancer (CRPC) MedDRA version: 14.1 Level: PT Classification code 10036909 Term: Prostate cancer metastatic System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: TORISEL
Pharmaceutical Form: Concentrate and solvent for solution for injection
Sponsors
CESAR Central European Society for Anticancer Drug Research EWIV
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: Inclusion Criteria: 1.Adult males over 18 years of age 2.Performance status 0 or 1 3.Patients with CRPC defined as confirmed rise of PSA levels after orchiectomy or LHRH agonist therapy 4.Progressive disease, defined as PSA progression by confirmed rising PSA levels 5.PSA at time of study entry = 2 ng/ml within 1 week prior to treatment (according Scher et al. 2008) 6.Bone metastasis and/or lymph node and/or visceral organ metastases allowed 7.Neutrophils = 1.5 x 10*9/L, platelet count = 100x10*9/L, hemoglobin = 5.6 mmol/L (10 g/dL) 8.Total bilirubin = 2 x upper limit of normal. 9.AST and/or ALT = 2.5 x upper limit of normal, or = 5 x upper limit of normal in case of liver metastases 10.Serum creatinine = 1.5 x upper limit of normal or creatinine clearance > 60 ml/min 11.Written informed consent 12.Androgen ablation will have to be continued, antiandrogens such as bicalutamide will have to be discontinued at least 2 weeks prior to the start of study treatment 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: 1.Prior Chemotherapy including estramustine (prior treatment is allowed in Phase I part) 2.Clinically symptomatic brain or meningeal metastasis 3.Receiving known strong CYP3A4 isoenzyme inhibitors and/or inducers 4.Any investigational drug within the 30 days before inclusion. Not recovered from prior biopsy, surgery, traumatic injury, and/or radiation therapy, as judged by the investigator 5.Nonhealing wound or ulcer 6.Grade = 3 hemorrhage within the past month 7.Any condition / concomitant disease not allowing chemotherapy with docetaxel, prednisone and temsirolimus in the discretion of the treating physician, like: Renal insufficiency requiring dialyses; congestive heart failure or uncontrolled angina pectoris; prior myocardial infarction within 6 months of start of chemotherapy; uncontrolled severe hypertension (failure of diastolic blood pressure to fall below 90 mm Hg despite the use of = 3 anti-hypertensive drugs) or arrhythmias; instable diabetes mellitus, ulceration from diabetes mellitus or other conditions not allowing high dose corticosteroids; effusions in pericardium, pleura or abdomen symptomatic and in need of being punctured 8.Known hypersensitivity to any of the components in the temsirolimus infusion or other medical reasons for not being able to receive adequate premedication (antihistamine agents) 9.Legal incapacity or limited legal capacity 10.Medical or psychological conditions that would not permit the patient to complete the study or sign informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective in the Phase I Part is to evaluate feasibility of dose level DL1 to DL3 and defining a recommended dose (RD) for the Phase II part using the dose levels DL1-DL3 of the phase I part. The primary objective in the study’s Phase II Part is to evaluate the activity of the addition of temsirolimus to standard treatment on the disease progression-free survival in patients with castration resistant prostate cancer receiving first-line docetaxel chemotherapy.;Secondary Objective: Secondary objectives in Phase I Part are the collection of safety data on the dose levels used in this part. Secondary objectives /endpoints of Phase II Part are the characterization of: overall response through the overall response rate, RR, disease control rate, CR+PR+SD, tolerability/safety, overall survival (OSChemotherapy), quality of life (QoL). ;Primary end point(s): Phase I Part: Primary endpoint is the Recommended Dose (RD) for the Phase II Part chosen between the three DLs based on the dose escalation scheme. Phase II Part: Disease Progression Free Survival assessed after 6 months quantified by the parameter DPFS-6mR, the 6-months Disease-Progression Free Survival Rate. DPFS-6mR is defined as the quotient of the number of patients who are disease progression free over the number of patients who are evaluable with respect to DPFS-6mR. | — |
Countries
Germany
Outcome results
None listed