Bristol Bladder Trial

Trial Title: Bristol Bladder Trial

NCT ID: NCT01616875

Condition: Infiltrating Bladder Urothelial Carcinoma

Conditions: Official terms:
Carcinoma
Cisplatin

Conditions: Keywords:
Bladder cancer
Transitional cell carcinoma
Urothelial cancer
Cisplatin
Cabazitaxel
Chemotherapy
Neo adjuvant chemotherapy

Study type: Interventional

Study phase: Phase 2

Overall status: Unknown status

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: Cabazitaxel + Cisplatin chemotherapy
Description: Cabazitaxel 15mg/m2 followed by cisplatin 70mg/m2 given intravenously on day 1 of each 3 weekly cycle for 4 cycles prior to radical cystectomy.
Arm group label: Cabazitaxel + Cisplatin chemotherapy

Other name: Jevtana

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

Criteria for eligibility:
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.

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Bristol Haematology + Oncology Centre, Horfield Road

Address:
City: Bristol
Zip: BS2 8ED
Country: United Kingdom

Start date: May 2012

Completion date: January 2023

Lead sponsor:
Agency: University Hospitals Bristol and Weston NHS Foundation Trust
Agency class: Other

Collaborator:
Agency: Sanofi
Agency class: Industry

Source: University Hospitals Bristol and Weston NHS Foundation Trust

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT01616875