Trial document

PLEASE NOTE:
This trial has been registered retrospectively.

drksid header

DRKS-ID: DRKS00003397

Trial Description

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Title

Prospectively randomized, double-blind, multicenter phase II trial comparing the efficacy of chemotherapy with gemcitabine plus cisplatin and sorafenib versus gemcitabine plus cisplatin and placebo in the treatment of advanced or metastatic urothelial carcinoma SUSE - AB 31/05

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Trial Acronym

SUSE - AB 31/05

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Trial comparing the efficacy of chemotherapy with gemcitabine plus cisplatin and sorafenib versus gemcitabine plus cisplatin and placebo in the treatment of advanced or metastatic urothelial carcinoma.
This study is based on the hypothesis that sorafenib can improve the efficacy of combination chemotherapy in patients with advanced urothelial cancer.
The main target is the 5 year survival free of recurrent disease.
Potential study participants are patients with advanced bladder cancer.

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Brief Summary in Scientific Language

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Organizational Data

DRKS-ID: DRKS00003397
Date of Registration in DRKS: 2012/01/13
Date of Registration in Partner Registry or other Primary Registry: 2010/10/01
Investigator Sponsored/Initiated Trial (IST/IIT): yes
Ethics Approval/Approval of the Ethics Committee: Approved
(leading) Ethics Committee No.: 06-2998, Ethik-Kommission der Medizinischen Fakultät der Universität Duisburg-Essen

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Secondary IDs

EudraCT-Number: 2005-006098-29
Primary Registry-ID: NCT01215266 (clinical-trials.gov)
BfArM-No.: 4031573

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Health Condition or Problem studied

ICD10: C67 - Malignant neoplasm of bladder
Free text: bladder cancer

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Interventions/Observational Groups

Arm 1: - Gemcitabin 1250 mg/m2, day 1 + 8, intravenous
- Cisplatin 70 mg/m2, day 2, intravenous
- Sorafenib 2 x 400 mg, day 3 - 21, orally
Arm 2: - Gemcitabin 1250 mg/m2, day 1 + 8, intravenous
- Cisplatin 70 mg/m2, day 2, intravenous
- Placebo 2 x 2 tablets, day 3 - 21, orally

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Characteristics

Study Type: Interventional
Study Type Non-Interventional: [---]*
Allocation: Randomized controlled trial
Blinding: Double or multiple blind
Who is blinded: [---]*
Control: Placebo
Purpose: Treatment
Assignment: Parallel
Phase: II
Off-label Drug use: Yes

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Primary Outcome

Progression free survival [ Time Frame: 5 years ]

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Secondary Outcome

- Response rates, time of response [ Time Frame: 5 years ]
- Time to progression [ Time Frame: 5 years ]
- Overall survival [ Time Frame: 5 years ]
- Evaluation and comparison in both treatment arms [ Time Frame: 5 years ]

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Countries of Recruitment

DE: Germany

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Locations of Recruitment

University Medical Center Charité - Universitätsmedizin Berlin - Campus Benjamin Franklin, Berlin
University Medical Center Johanniter-Krankenhaus, Stendal
University Medical Center Universitätsklinikum Kassel, Kassel
University Medical Center Universitätsklinikum Weiden, Weiden
University Medical Center Krankenhaus St. Georg, Hamburg
University Medical Center Technische Universität, München
University Medical Center Urologie, Köln
University Medical Center Uniklinikum Dresden C.G.C. Urologie, Dresden
University Medical Center Urologie, Münster
University Medical Center Urologie, Düsseldorf
Medical Center Klinik für Allgemeine Chirurgie, Viszeral-, Gefäß- und Kinderchirurgie, Saarland
University Medical Center Universitätsklinikum Essen, Essen
University Medical Center Eppendorf Urologie, Hamburg
University Medical Center Urologische Klinik und Poliklinik, Saarland
University Medical Center Urologie, Tübingen
University Medical Center Urologische Klinik, Ulm

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Recruitment

Planned/Actual: Actual
(Anticipated or Actual) Date of First Enrollment: 2006/10/09
Target Sample Size: 132
Monocenter/Multicenter trial: Multicenter trial
National/International: National

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Inclusion Criteria

Gender: Both, male and female
Minimum Age: 18 Years
Maximum Age: 99 Years

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Additional Inclusion Criteria

- 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

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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

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Addresses

Primary Sponsor
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- Universitätsklinikum Essen
- Hufelandstraße 55
- 45147 Essen
- Germany
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- Telephone: [---]*
- Fax: [---]*
- E-mail: [---]*
- URL: http://www.uniklinikum-essen.de
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Contact for Scientific Queries
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- Ltd. Oberärztin der Klinik u. Poliklinik für Urologie, Kinderurologie und urologische Onkologie Universitätsklinikum Essen
- Ms. Prof. Dr. Susanne Krege
- Hufelandstr. 55
- 45122 Essen
- Germany
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- Telephone: 0201/723-32 60
- Fax: 0201/723-31 51
- E-mail: susanne.krege at uni-essen.de
- URL: [---]*
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Contact for Public Queries
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- Ltd. Oberärztin der Klinik u. Poliklinik für Urologie, Kinderurologie und urologische Onkologie Universitätsklinikum Essen
- Ms. Prof. Dr. Susanne Krege
- Hufelandstr. 55
- 45122 Essen
- Germany
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- Telephone: 0201/723-32 60
- Fax: 0201/723-31 51
- E-mail: susanne.krege at uni-essen.de
- URL: [---]*
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Sources of Monetary or Material Support

Commercial (pharmaceutical industry, medical engineering industry, etc.)
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- Bayer Vital GmbH
- Mr.
- Gebäude K56
- 51368 Leverkusen
- Germany
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- Telephone: 0214 / 30-1
- Fax: [---]*
- E-mail: [---]*
- URL: [---]*
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Status

Recruitment Status: Recruiting stopped after recruiting started
Study Closing (LPLV): [---]*

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Trial Publications, Results and other Documents

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