CESAR Study in Prostrate Cancer with Temsirolimus added to standard Docetaxel therapy (CEPTAS)

• Conditions: castration resistant prostate cancer (CRPC); MedDRA version: 14.1Level: PTClassification code 10036909Term: Prostate cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

• Registration Number: EUCTR2010-018370-21-DE
• Lead Sponsor: CESAR Central European Society for Anticancer Drug Research EWIV

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-03-01
• Last Update Posted: 8 December 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: 122

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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified