Prospektiv, randomisierte, doppelblinde, multizentrische Phase-II- Studie zum Vergleich der Wirksamkeit einer Chemotherapie mit Gemcitabin plus Cisplatin und Sorafenib (BAY 43-9006) versus Gemcitabin plus Cisplatin und Plazebo in der Therapie des lokal fortgeschrittenen bzw. metastasierten Urothelkarzinoms - SUSE
- Conditions
- rothelcarcinoma of the bladder
- Registration Number
- EUCTR2005-006098-29-DE
- Lead Sponsor
- niversitätsklinikum Essen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 132
•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
•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 < 60mmHG), hematopoetic (e.g. severe bone marrow suppression), hepatic or renal diseases
•Patients with hardly controlled diabetes mellitus
•Severe bacterial or fungal infection (> 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method