Urothelcarcinoma of the bladder
Conditions
Interventions
Product Name: Sorafenib
Product Code: BAY 43-9006
Pharmaceutical Form: Tablet
INN or Proposed INN: Sorafenib (BAY 43-9006)
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration n
Sponsors
Universitätsklinikum Essen
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Men and women 18 years or older • ECOG score 0-1 • Life expectancy of at least 12 weeks • Female patient of child-bearing potential: with negative pregnancy testing and adequate contraception • men with adequate contraception during 3 months since finishing Sorafenib therapy • Histological or cytological evidence of 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 uni-dimensional measurable lesion by CT-scan or MRI according to RECIST-criteria • Sufficient haematologic, renal, hepatic and coagulation function • WBC > 1.500 cells/µl • Hemoglobin > 9g/dl • Platelet count > 100.000/nl • Serum creatinine below 2 x upper limit of reference value or creatinine clearance at least 45ml/min • Total serum bilirubine below 1.5 x upper limit of reference value • Serum GOT/GPT below 2.5 x upper limit of reference value; in case of liver metastases below 5 x upper limit of reference value • Alkaline phosphatase below 5 x upper limit of reference value • Amylase / Lipase below 1.5 x upper limit of reference value • INR and PTT below 1.5 x upper limit of reference value • Information of the patient about the study and provision of a written informed consent according to actual medical law and the ethical principles of the institutional review board 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: • Absence of one of the above mentioned criteria • Requiring dialysis after nephrectomy • Patients with primary tumors or metastases of the brain • Previous or actual severe cardiac disease (New York Heart Association Class III or IV), active angina pectoris or ischaemia, myocardial infarction within the last 6 months, cardiac arrhythmia requiring treatment (ß-blocker, digoxin are allowed) • Patients with uncontrolled hypertension, systolic blood pressure > 150mgHG or diastolic blood pressure > 90mmHG despite optimal treatment • Patients with thrombotic or embolic events i.e. apoplectic insult or lung embolism • Patients with recent history or documented bleeding diathesis • Significant neurological or psychiatric diseases including dementia and epilepsia • Severe inflammatory eye-disease or auditory damage • Pulmonal (pO2 grade II [NCI-CTC, version 3]) • Chronic hepatitis B or C, HIV-infection • Immune mediated diseases • Allergic reactions concerning one of the given medicines • Previous kidney transplantation • Previous autologic bone marrow transplantation or stem cell application within the last 4 months prior to inclusion • Secondary existing malignoma or cancer within the last 5 years (besides basalioma, carcinoma in situ of the cervix, incidental carcinoma of the prostata) • Pregnancy and breast- feeding • Insufficient cooperation, foreseen problems concerning follow-up, psychiatric diseases, drug abuse, missing legal capacity of the patient • Previous chemo- or immunotherapy • Simultaneous treatment with other antitumor therapy at the begin of the study • Intravesical chemotherapy within the last 4 weeks • Radiation therapy within the last 4 weeks • Previous radiation for all lesions used for evaluation of tumor remission • Extended surgery, open biopsy or significant injuries within the last four weeks prior to inclusion • Significant wound healing disorder, ulcera or bone fractures within the last 4 weeks prior to inclusion
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Progression free survival;Secondary Objective: Response rate, Time to progression, Overall survival, Toxicity, Quality of Life;Primary end point(s): Progression of disease | — |
Countries
Germany
Outcome results
None listed