Sorafenib in Urothelium Cancer of Bladder

This study has been terminated.
(Slow recruitment)
Sponsor:
Collaborator:
University Hospital, Essen (Sponsor)
Information provided by (Responsible Party):
Association of Urogenital Oncology (AUO)
ClinicalTrials.gov Identifier:
NCT01215266
First received: October 1, 2010
Last updated: September 7, 2011
Last verified: September 2011
  Purpose

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


Condition Intervention Phase
Bladder Cancer
Drug: Sorafenib
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
Official Title: 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 AB 31/05 - RUTT 204 - SUSE

Resource links provided by NLM:


Further study details as provided by Association of Urogenital Oncology (AUO):

Primary Outcome Measures:
  • Progression free survival [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Response rates, time of response [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Time to progression [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Evaluation and comparison in both treatment arms [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]

Enrollment: 98
Study Start Date: October 2006
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Sorafenib Drug: Sorafenib
Day 3-21 2x2 800 mg(milligram) daily
Other Name: Prüfsubstanz
Placebo Comparator: Placebo Drug: Placebo
Day 3-21 2x2 800 mg(milligram) daily
Other Name: Plazebo

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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").

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01215266

Sponsors and Collaborators
Association of Urogenital Oncology (AUO)
University Hospital, Essen (Sponsor)
Investigators
Study Chair: Susanne Krege, Prof. Dr. Universität Duisburg-Essen
  More Information

No publications provided

Responsible Party: Association of Urogenital Oncology (AUO)
ClinicalTrials.gov Identifier: NCT01215266     History of Changes
Other Study ID Numbers: AB 31/05 RUTT 204, 2005-006098-29
Study First Received: October 1, 2010
Last Updated: September 7, 2011
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Association of Urogenital Oncology (AUO):
Bladder cancer
Chemotherapy
Urothelium cancer

Additional relevant MeSH terms:
Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Urinary Bladder Diseases
Urologic Diseases
Sorafenib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 22, 2014