Clinical trial NCT01215266 (phase 2, status: terminated)
Conditions: bladder cancer
ICD codes: D30.3, C67.5, C67.9, C79.11, C67.0, C67.1, D41.4
Drugs: sorafenib, placebo
SMILES: CNC(=O)C1=NC=CC(OC2=CC=C(NC(=O)NC3=CC(=C(Cl)C=C3)C(F)(F)F)C=C2)=C1, CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O
Reason stopped: 
    slow recruitment
  
Eligibility criteria:

        Inclusion Criteria:

        Men and Women > 18 years

          -  Condition ECOG(Eastern Cooperative Oncology Group) 0-1

          -  Life expectancy at least 12 weeks

          -  Women in conceptional age: negative pregnancy test and adequate contraception (oral
             contraceptive, spiral); at men adequate contraception of the man (condom use) to 3
             months after discontinuation of therapy with sorafenib

          -  Histologically or cytologically proven urothelial carcinoma of the bladder or upper
             urinary tract

          -  Locally advanced or metastatic urothelial carcinoma of the bladder or upper urinary
             tract (T3b,T4/ N+/M+)

          -  At least one unidimensional measurable lesion on CT(Computed Tomography) or
             MRI(Magnetic resonance imaging) according to RECIST(Response Evaluation Criteria in
             Solid Tumors) criteria

          -  Adequate hematologic, renal, hepatic and coagulation-physiological functions

          -  Leukocytes > 1.500 cells /ml (per milliliter)

          -  Hemoglobin >9g/dl(gram per deciliter)

          -  Platelet > 100000 /ml

          -  Serum creatinine < 2 x upper limit of normal or creatinine clearance ≥ 45 ml/min
             (milliliter per minute)

          -  Total Bilirubin < 1,5 x upper limit of normal

          -  GOT/GPT (glutamate-oxalacetate-transaminase/glutamate-pyruvate-transaminase) < 2,5 x
             upper limit of normal, at liver metastases < 5x upper limit of normal

          -  alkaline phosphates < 5 x upper limit of normal

          -  Amylase/ Lipase < 1,5 x upper limit of normal

          -  INR(International Normalized Ratio) und PTT(Partial Thromboplastin Time) < 1,5 x upper
             limit of normal

          -  Informing the patient about the study and the present written consent to participate
             after clarification in accordance with the stipulations of AMG(german drug law), and
             the principles of the Ethics Committee ("informed consent").

        Exclusion Criteria:

          -  Absence of the above inclusion criteria

          -  Dialysis after nephrectomy

          -  Patients with brain tumors and / or brain metastases

          -  Previous or existing serious cardiovascular (grade III - IV according to NYHA(New York
             Heart Association)) disease, active angina pectoris or ischemia, myocardial infarction
             within 6 months prior to enrollment, or patients with serious cardiac arrhythmias
             requiring antiarrhythmic therapy (beta blockers and digoxin are permitted)

          -  Patients with uncontrolled high blood pressure, systolic blood pressure> 150 mm Hg or
             diastolic pressure> 90 mmHg despite optimal medical treatment

          -  Patients with thrombotic or embolic events such as stroke or pulmonary embolism

          -  Patients with recently or known bleeding diathesis

          -  Known significant neurological or psychiatric diseases including dementia and
             epileptic seizures

          -  Serious inflammatory eye disease, hearing impairment

          -  Pulmonary (pO2(Blood oxygen) <60 mm Hg(Millimeters of mercury)), hematopoietic
             (eg(exempli gratia) severe bone marrow aplasia), hepatic or renal disease

          -  Patients with poorly controlled diabetes mellitus

          -  Serious bacterial or fungal infections(>Grade 2 NCI-CTC(National Cancer
             Institute-Common Terminology Criteria) Version 3)

          -  chronic hepatitis B or C, HIV(human immunodeficiency virus) infection

          -  Autoimmune disease

          -  Allergic reactions to be used in respect of a drug

          -  prior organ transplantation

          -  prior autologous bone marrow transplant or stem cell transferred within the last 4
             months before study

          -  Manifesto, second malignancy or other malignancy within the past 5 years (except basal
             cell carcinoma, carcinoma in situ of the cervix, incidental prostate carcinoma)

          -  Pregnancy or breast-feeding

          -  Lack of cooperation and the ability to cooperate, predictable problems with the
             aftercare, psychiatric disorders, substance abuse, lack of capacity of the patient

          -  Participation in other treatment studies in the last 4 weeks

          -  Previous treatment with chemotherapy or immunotherapy

          -  Simultaneous treatment with other anti-tumor therapies after study start

          -  Intravesical chemotherapy within the last 4 weeks

          -  Irradiation within the last 4 weeks

          -  Previous radiation therapy, when all were irradiated to the assessment of tumor
             response used lesions

          -  Complex operations, open biopsy or significant injuries within the last 4 weeks before
             study

          -  Serious wound healing disorder, ulcers or bone fractures in the last 4 weeks before
             study