26:I[164923,["/_next/static/immutable/chunks/0x-9rc1bm-510.js","/_next/static/immutable/chunks/0u73ovrok9bmr.js","/_next/static/immutable/chunks/3t9ifrnugpnlb.js","/_next/static/immutable/chunks/3gdp0tzp2t65u.js","/_next/static/immutable/chunks/0qexc5596g7lf.js","/_next/static/immutable/chunks/3nkl8euu6dycn.js","/_next/static/immutable/chunks/28p3k9kvs3dfa.js","/_next/static/immutable/chunks/04j_o97cgxn2x.js","/_next/static/immutable/chunks/18bybpoq919w1.js"],"ClinicalTrialDetail"] 27:T16f7,Inclusion Criteria Phase I Part: * Adult males ≥18 years of age. * Patients with CRPC defined as confirmed rise of PSA levels after orchiectomy or LHRH agonist based therapy. * Progressive disease, defined as PSA progression by confirmed rising PSA levels. * PSA at time of study entry ≥2ng/ml within 1 week prior to treatment (according to Scher 2008). * Bone metastasis and/or lymph node and/or visceral organ metastases allowed. Measurable and non measurable disease allowed. * Performance status (PS) 0-1 ECOG. * Signed written informed consent. * White blood cell count (WBC) ≥4x10\^9/L with neutrophils ≥1.5x10\^9/L, platelet count ≥100x10\^9/L, hemoglobin ≥9g/dL. * Total bilirubin \<=2 x upper limit of normal. * AST and ALT \<=2.5 x upper limit of normal, or \<=5 x upper limit of normal in case of liver metastases. * Serum creatinine \<=1.5 x upper limit of normal or creatinine clearance \> 60 ml/min. * Androgen ablation will have to be continued. Antiandrogens such as bicalutamide will have to be discontinued at least 4 weeks prior to the start of study treatment. Exclusion Criteria Phase I Part: * Clinically symptomatic brain or meningeal metastasis. * Receiving known strong CYP3A4 isoenzyme inhibitors and/or inducers. * 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. * Nonhealing wound or ulcer. * Grade ≥ 3 hemorrhage within the past month. * 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. * 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). * Legal incapacity or limited legal capacity * Medical or psychological conditions that would not permit the patient to * complete the study or sign informed consent. Inclusion Criteria Phase II Part, Chemotherapy Period: * Adult males ≥ 18 years of age. * Patients with CRPC defined as confirmed rise of PSA levels after orchiectomy or LHRH agonist based therapy * Progressive disease, defined as PSA progression by confirmed rising PSA levels * PSA at time of study entry ≥ 2ng/ml within 1 week prior to treatment (according to Scher 2008). * Bone metastasis and/or lymph node and/or visceral organ metastases allowed. Measurable and non measurable disease allowed. * Performance status (PS) 0-1 ECOG. * Signed written informed consent. * White blood cell count (WBC) ≥4x10\^9/L with neutrophils ≥1.5x10\^9/L, platelet count ≥100x10\^9/L, hemoglobin ≥9g/dL. * Total bilirubin \<= 2 x upper limit of normal. * AST and ALT \<=2.5 x upper limit of normal, or \<=5 x upper limit of normal in case of liver metastases. * Serum creatinine \<=1.5 x upper limit of normal or creatinine clearance \>60 ml/min. * Androgen ablation will have to be continued. Antiandrogens such as bicalutamide will have to be discontinued at least 4 weeks prior to the start of study treatment. Exclusion Criteria Phase II Part, Chemotherapy Period: * Prior Chemotherapy. * Clinically symptomatic brain or meningeal metastasis. * Receiving known strong CYP3A4 isoenzyme inhibitors and/or inducers. * 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. * Nonhealing wound or ulcer. * Grade ≥ 3 hemorrhage within the past month. * 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. * 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). * Legal incapacity or limited legal capacity. * Medical or psychological conditions that would not permit the patient to complete the study or sign informed consent. Inclusion Criteria Phase II Part, Maintenance Period: * Completed 8 cycles (up to 26 weeks) treatment in Arm A * White blood cell count (WBC) ≥4x10\^9/L with neutrophils ≥1.5x10\^9/L, platelet count ≥100x10\^9/L, hemoglobin ≥9g/dL. * Total bilirubin \<=2 x upper limit of normal. * AST and ALT \<=2.5 x upper limit of normal, or \<=5 x upper limit of normal in case of liver metastases. * Serum creatinine \<=1.5 x upper limit of normal or creatinine clearance \>60 ml/min. * General condition sufficient to allow therapy with temsirolimus. * Signed Informed Consent. Exclusion Criteria Phase II Part, Maintenance Period: * Disease Progression in the first 8 cycles (up to 26 weeks).25:["$","$L26",null,{"trial":{"nctId":"NCT01206036","briefTitle":"CESAR Study in Prostate Cancer With Temsirolimus Added to Standard Docetaxel Therapy (CEPTAS)","officialTitle":"Phase I/II Study With Temsirolimus Versus no add-on in Patients With Castration Resistant Prostate Cancer (CRPC) Receiving First-line Docetaxel Chemotherapy","briefSummary":"In this Phase I study safety of the combination of Docetaxel and Temsirolimus needs to be shown before the study can be expanded into a Phase II study to examine the activity of a safe combination of Temsirolimus and Docetaxel in a comparison with Docetaxel alone.","detailedDescription":"The purpose of this Phase I study is to evaluate feasibility of dose levels DL1, DL2 and DL3 (which are combinations of Temsirolimus and Docetaxel) and defining a recommended dose (RD) for the Phase II part using these dose levels in a dose escalating scheme.\n\nSecondary objectives are the collection of safety data on the dose levels used in this part.","overallStatus":"COMPLETED","phase":"PHASE1/PHASE2","studyType":"INTERVENTIONAL","conditions":["Prostatic Neoplasms"],"interventions":[{"type":"DRUG","name":"Docetaxel","description":"DL 1: Docetaxel 60mg/m\\^2, Temsirolimus 15mg. DL 2: Docetaxel 60mg/m\\^2, Temsirolimus 25mg. DL 3: Docetaxel 75mg/m\\^2, Temsirolimus 25mg. One cycle is defined as a 3 week period (21 days) where docetaxel is given on day 1, and temsirolimus on days 1, 8 and 15."},{"type":"DRUG","name":"Temsirolimus","description":"DL 1: Docetaxel 60mg/m\\^2, Temsirolimus 15mg. DL 2: Docetaxel 60mg/m\\^2, Temsirolimus 25mg. DL 3: Docetaxel 75mg/m\\^2, Temsirolimus 25mg. One cycle is defined as a 3 week period (21 days) where docetaxel is given on day 1, and temsirolimus on days 1, 8 and 15."}],"keywords":["castration","prostate cancer","castration resistant prostate cancer","PSA","Docetaxel","Temsirolimus","disease progression free survival","DPFS","dose escalation"],"locations":[{"facility":"CESAR Study Center","city":"Essen","state":"","country":"Germany","zip":"$undefined","lat":51.45657,"lng":7.01228},{"facility":"CESAR Study Center","city":"Freiburg im Breisgau","state":"","country":"Germany","zip":"$undefined","lat":47.9959,"lng":7.85222}],"eligibilityCriteria":"$27","minAge":18,"maxAge":null,"sex":"MALE","healthyVolunteers":false,"leadSponsor":"Central European Society for Anticancer Drug Research","collaborators":null,"contacts":null,"startDate":"$D2010-07-01T00:00:00.000Z","completionDate":"$D2015-10-01T00:00:00.000Z","primaryCompletionDate":"$D2014-09-01T00:00:00.000Z","firstPostDate":"$D2010-09-21T00:00:00.000Z","lastUpdatePostDate":"$D2016-01-27T00:00:00.000Z","enrollmentCount":19,"enrollmentType":"ACTUAL","aiSummary":"$undefined","aiSummaryGeneratedAt":null,"id":"$undefined","createdAt":"$undefined","updatedAt":"$undefined"}}]

What this study is about