Locally progressed and / or metastasized hormon refractory prostate carcinoma Classification code 10001203
Conditions
Interventions
Product Name: Sorafenib
Product Code: BAY 43-9006
Pharmaceutical Form: Tablet
INN or Proposed INN: 4-{4-[3-(4-Chloro-3-trifluoromethyl-phenyl) -ureido]-phenoxy}-pyridine-2-carboxylic acid methylamide-
Sponsors
Urologische Klinik und Poliklinik, Klinikum Großhadern der LMU München
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: Main inclusion criteria - Histologically or cytologically confirmed adenocarcinoma of the prostate - Metastasized adenocarcinoma of the prostate that is hormonrefractory, this means no more response to hormon therapy, measured by a continous increase of Serum-PSA levels under preceded therapy - Documented progression under the lastly aplied therapy (a definite increase of >20% that is confirmed by two successive measurements with a time-lag of at least two weeks, or a 25% increase of measurable lesions that are verified by radiologic examinations) - Male patients > 18 years of age - Preceded hormon therapy - ECOG Performance Status = 1 - An adequate hematologic, renal, cardial and hepatic function according to the following parameters: - Neutrophil count = 1500/mm3 - Thrombocytes = 100.000 mm/3 - Hemoglobine = 9 g/dl (6,2 mmol/l) - Creatinine = 1,5 x of the upper limit of the normal range (ULN), oder Creatinine Plasma-Clearance = 45 ml/min - Total bilirubin = 1,5 x ULN - AST (SGOT) and ALT (SGPT) = 2,5 x ULN - Alcalic Phosphatase = 5 x ULN - Amylase und Lipase =65 years) F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Main exclusion criteria - Acquainted disorders of the calcium metabolism - Curatively treated superficial TCC = 2 years without recidive - Previous or recent neoplasies except for curatively treated in situ carcinomata and basal cell carcinomata of the skin as well as curatively treated malignomata with no recurrence within the last 5 years - Patients with brain tumors or metastases - Existent peripheric neutropathies Grade 2 - Chronical diarrhoeas (now or in the anamnesis) - Other severe concomitant diseases: a) Patients with congestive heart insufficency; active angina pectoris or ischemia; myocardial infarctions within 6 months prior to the trial initiation or patientes with severe cardial arrhythmias that require an antiarrhythmic therapy (beta blockrs and digoxine are permitted) b) Patients with uncontrolled blood pressure; systolic RR > 150 mm Hg or diastolic pressure > 90 mm Hg despite optimal medical treatment c) Patients with thrombotic or embolic events like apoplexia or lung embolia d) Patients with recent or wellknown hemorrhagic diathesis e) Wellknown significant neurological or psychiatrical disorders including dementia and epileptic seizures f) Patients with severe infections (>Grade 2 NCI-CTC Version 3.0) g) Ulcerations, unstable diabetes mellitus or other contraindications concerning the aplication of highly dosed corticosteriods h) Untreated vena-cava-syndrome i) Wellknown ascites or pericard effusion j) Wellknown symptomatic pleural effusion that has to be punctured k) Infection with HIV or chronical Hepatits B or C - Missing attendance or incapacity to observe the measures of treatment and examination - Lack of compliance Inadmissible therapies or drugs before or during the treatment with the study medication: - Chemo- or Immunotherapy prior to the trial start - Simultaneous treatment with additional antitumor therapies (such as chemotherapy, immunotherapy, signal transduction inhibitors or hormone therapy) except for bisphosphonates and LHRH antagonists in a constant dosage (at least since four weeks prior to trial beginning) whereas this therapy should be continued then - Former treatment with experimental or approved angiogenesis inhibitors - Radiation therapy during three weeks prior to the trial start - Preceded radiation therapy if over 25% of the bone marrow were affected - Major surgery, open biopsies or sigificant traumata during the last four weeks prior to the trial start - Severe wound healing disorders, ulcera or bone fractures during the last four weeks prior to the trial start - Patients with organ transplantations during the last four months prior to the trial start - Preceded application of substances that target the ras – signal ways or EGFR - “Biologic response modifiers” e.g. G-CSF or GM-CSF within three weeks prior to the trial start ( G-CSF and other hematopoetic growth factors are only to be applied for the management of acute toxicities e.g. neutropenic fever if they are medically indicated or according to the discretionary authority of the trial investigator) - Participation in other clinical trials within 30 days prior to the therapy start - Treatment with rifampicine or saint-john’s-wort (hypericum) during the trial - Therapy with digitalis-glycosides or thiacid-diuretics
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary efficacy objective of the trial is the comparison of Sorafenib vs Placebo in combination with Docetaxel regarding a progression free survival which is measured by the bio-indicator cPSA in the blood serum (prostate-specific antigen). In terms of the clinical laboratory examination a progress is defined by an increase of the cPSA-level of = 50%.This increase must be approved after two weeks. ;Secondary Objective: Comparison of the disease control rates (CR+PR+SD) Comparison of the overall survival times Comparison of the Time to Progression Comparison of response rates measured by cPSA Comparison of response rates measured by RECIST Comparison of progression free survival measured by RECIST Comparison of the tolerance profiles in both treatment groups PSA response period in both treatment groups Comparison of the overall response between both treatment groups ;Primary end point(s): TTP | — |
Countries
Germany
Outcome results
None listed