Sorafenib in Urothelium Cancer of Bladder

Association of Urologic Oncology (AUO)

Status and phase

Terminated

Phase 2

Conditions

Bladder Cancer

Treatments

Drug: Sorafenib

Drug: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT01215266

AB 31/05 RUTT 204

2005-006098-29 (EudraCT Number)

Details and patient eligibility

About

The purpose of this study is to evaluate the use of Sorafenib additionally to gemcitabine and cisplatin in bladder cancer.

Full description

A controlled, double-blind, randomized study to evaluate the influence of Sorafenib in bladder cancer patients additionally to chemotherapy with gemcitabine and cisplatin compared to placebo.

Enrollment

98 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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