Bristol Bladder Trial

Inclusion Criteria:

• Age ≥18 years
• Histologically confirmed primary transitional cell carcinoma (TCC) of the urinary bladder
• T2 to T4 disease, N0 M0 determined by computerised tomography (CT) imaging and biopsy or transurethral resection
• Eastern Co-operative Oncology Group (ECOG) Performance status 0 or 1
• Glomerular filtration rate (GFR) ≥60ml/min.
• Written, informed consent

Exclusion Criteria

• ECOG Performance Status ≥ 2
• Lymph node involvement or metastatic disease
• Prior surgery (except transurethral resection of bladder tumour), radiation, che-motherapy, or other anti-cancer therapy within 4 weeks prior to enrolment
• Active Grade ≥2 peripheral neuropathy
• Active secondary cancers
• History of severe hypersensitivity reaction (≥Grade 3) to polysorbate 80 containing drugs
• Other concurrent serious illness or medical conditions
• Inadequate organ function as evidenced by peripheral blood counts at enrolment:
• Electrocardiogram (ECG) evidence of uncontrolled cardiac arrhythmias, angina pectoris, and/or hypertension, history of congestive heart failure, or myocardial infarction within last 6 months.
• Uncontrolled diabetes mellitus.
• Active uncontrolled gastro-oesophageal reflux disease (GORD).
• Active infection requiring systemic antibiotic or anti-fungal medication
• Participation in another clinical trial with any investigational drug within 30 days prior to study enrolment.
• Concurrent or planned treatment with strong inhibitors of cytochrome P450 3A4/5. A 1-week washout period is necessary for patients who are already on these treatments.
• Concurrent or planned treatment with strong inducers of cytochrome P450 3A4/5. A 1-week washout period is necessary for patients who are already on these treatments.
• Contraindications to cisplatin.
• Patient with reproductive potential not implementing an accepted and effective method of contraception.