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Sponsor: University Hospitals Bristol and Weston NHS Foundation Trust
Conditions: Infiltrating Bladder Urothelial Carcinoma
Interventions: Cabazitaxel + Cisplatin chemotherapy
Countries: United Kingdom
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
Sex: ALL
Age: 18 Years to —
Healthy volunteers: No
Study type: INTERVENTIONAL
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, chemotherapy, 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.
- Bristol, United Kingdom