Bristol Bladder Trial

• Status: Active, not recruiting
• Trial end date: 2023-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospitals Bristol and Weston NHS Foundation Trust; University Hospitals Bristol NHS Foundation Trust
• Collaborator: Sanofi
• Treatments: Cisplatin

Criteria

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.