Bristol Bladder Trial

Sponsor

University Hospitals Bristol and Weston NHS Foundation Trust (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT01616875

Collaborator

Sanofi (Industry)

Enrollment

Location

Arm

128

Duration (Months)

0.2

Patients Per Site Per Month

Study Details

Study Description

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.

Contrast Magnetic resonance imaging (MRI ) scans will be taken at baseline and after cycle 1 and cycle 3.
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

Condition or Disease	Intervention/Treatment	Phase
Infiltrating Bladder Urothelial Carcinoma	Drug: Cabazitaxel + Cisplatin chemotherapy	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

28 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Phase II Trial of Combination Cabazitaxel and Cisplatin Chemotherapy in the Neo-adjuvant Treatment of Transitional Cell Carcinoma of the Urinary Bladder

Study Start Date :

May 1, 2012

Actual Primary Completion Date :

Nov 1, 2017

Anticipated Study Completion Date :

Jan 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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	Drug: 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. Other Names: Jevtana

Arm

Intervention/Treatment

Experimental: 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

Drug: 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.

Other Names:

Jevtana

Outcome Measures

Primary Outcome Measures

Overall pathological response rate [Histological assessment of radical cystectomy specimen expected to be 15 weeks after commencing study chemotherapy]

Secondary Outcome Measures

To record progression free survival [Up to 5 years following radical cystectomy]
From date of registration until the date of first documented progression or date of death from any cause whichever came first.
To assess quality of life [Up to 13 weeks from baseline]
EQ-5D and EORTC QLQC30 and BLM30 will be assessed at baseline and following each cycle of chemotherapy
To record side effects and tolerability of treatment [Up to 13 weeks from baseline]
Common toxicity criteria adverse events (CTC AE ) Version 4.03 will be assessed at baseline and following each cycle of chemotherapy
Overall survival [Up to 5 years following radical cystectomy]
From the date of registration to the date of death from any cause.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.