Bristol Bladder Trial

University Hospitals Bristol and Weston NHS Foundation Trust

Status and phase: Unknown; Phase 2

Conditions: Infiltrating Bladder Urothelial Carcinoma

Treatments: Drug: Cabazitaxel + Cisplatin chemotherapy

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01616875

2011-004090-82 (EudraCT Number)

ON/2011/3775

Details and patient eligibility

About

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

Enrollment: 28 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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28 participants in 1 patient group

Cabazitaxel + Cisplatin chemotherapy

Experimental group

Description:

Cabazitaxel 15mg/m2 Intravenous (IV)followed by Cisplatin 70mg/m2 IV on day 1 of each 21 day cycle for 4 cycles

Treatment:

Drug: Cabazitaxel + Cisplatin chemotherapy