Sorafenib in Urothelium Cancer of Bladder

NCT ID: NCT01215266

Last Updated: 2011-09-08

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 98 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-10-31
• Study Completion Date: 2011-06-30

Brief Summary

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

Detailed 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.

Conditions

Bladder Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Sorafenib

Group Type: ACTIVE_COMPARATOR

Sorafenib

Intervention Type: DRUG

Day 3-21 2x2 800 mg(milligram) daily

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Day 3-21 2x2 800 mg(milligram) daily

Interventions

Sorafenib

Day 3-21 2x2 800 mg(milligram) daily

Intervention Type: DRUG

Placebo

Day 3-21 2x2 800 mg(milligram) daily

Intervention Type: DRUG

Other Intervention Names

Prüfsubstanz; Plazebo

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").

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Essen

OTHER

Sponsor Role: collaborator

Association of Urologic Oncology (AUO)

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Susanne Krege, Prof. Dr.

Role: STUDY_CHAIR

Universität Duisburg-Essen

Other Identifiers

2005-006098-29

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

AB 31/05 RUTT 204

Identifier Type: -

Identifier Source: org_study_id