Sorafenib in Urothelium Cancer of Bladder

NCT01215266 | Terminated Phase 2 DMC

• 2 other identifiers: AB 31/05 RUTT 2042005-006098-29
• Study Type: interventional
• Target: 98
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Bladder Cancer

Keywords

Bladder cancer; Chemotherapy; Urothelium cancer

Outcome Measures

Primary Outcomes (1)

• Progression free survival

  5 years

Secondary Outcomes (4)

• Response rates, time of response

  5 years

• Time to progression

  5 years

• Overall survival

  5 years

• Evaluation and comparison in both treatment arms

  5 years

Study Arms (2)

Sorafenib

ACTIVE COMPARATOR

Drug: Sorafenib

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Sorafenib DRUG

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

Also known as: Prüfsubstanz

Sorafenib

Placebo DRUG

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

Also known as: Plazebo

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Association of Urologic Oncology (AUO): lead
• University Hospital, Essen: collaborator

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Interventions

Sorafenib

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Phenylurea Compounds; Urea; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Niacinamide; Nicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Study Officials

• Susanne Krege, Prof. Dr.

  Universität Duisburg-Essen

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 1, 2010
• First Posted: October 6, 2010
• Study Start: October 1, 2006
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2011
• Last Updated: September 8, 2011

Record last verified: 2011-09