Bristol Bladder Trial

NCT ID: NCT01616875

Last Updated: 2020-11-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-05-31
• Study Completion Date: 2023-01-31

Brief 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

Conditions

Infiltrating Bladder Urothelial Carcinoma

Keywords

Bladder cancer; Transitional cell carcinoma; Urothelial cancer; Cisplatin; Cabazitaxel; Chemotherapy; Neo adjuvant chemotherapy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cabazitaxel + Cisplatin chemotherapy

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

Group Type: EXPERIMENTAL

Cabazitaxel + Cisplatin chemotherapy

Intervention Type: DRUG

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.

Interventions

Cabazitaxel + Cisplatin chemotherapy

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.

Intervention Type: DRUG

Other Intervention Names

Jevtana

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sanofi

INDUSTRY

Sponsor Role: collaborator

University Hospitals Bristol and Weston NHS Foundation Trust

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Amit K Bahl

Role: PRINCIPAL_INVESTIGATOR

University Hospitals Bristol and Weston NHS Foundation Trust

Locations

Bristol Haematology + Oncology Centre, Horfield Road

Bristol, , United Kingdom

Countries

United Kingdom

Other Identifiers

2011-004090-82

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

ON/2011/3775

Identifier Type: -

Identifier Source: org_study_id