EUCTR2005-006098-29-DE进行中（未招募）不适用
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
niversitätsklinikum Essen0 个研究点目标入组 132 人开始时间: 2006年9月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 132
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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
排除标准
- •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
研究者
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