Bristol Bladder Trial
Bristol Bladder Trial
26 patients with invasive primary transitional cell carcinoma of the bladder will receive 4
 cycles of combination chemotherapy consisting of Cabazitaxel and Cisplatin both given
 intravenously on day 1 of each 3 weekly cycle prior to radical cystectomy, to evaluate the
 overall response rate and to determine whether this approach warrants further research of a
 phase II/III study.Participation in 2 sub studies will also be offered to the participants.

 1. Contrast Magnetic resonance imaging (MRI ) scans will be taken at baseline and after
 cycle 1 and cycle 3.

 2. A pilot sub study involving the circulating tumour cell concentration from blood samples
 taken at baseline, prior to each cycle of chemotherapy and prior to surgery
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.