Bristol Bladder Trial

NCT01616875 | Completed Phase 2 Results

• 2 other identifiers: ON/2011/37752011-004090-82
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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. 1.Contrast Magnetic resonance imaging (MRI ) scans will be taken at baseline and after cycle 1 and cycle 3.
2. 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

Outcome Measures

Primary Outcomes (1)

• Overall Pathological Response Rate

  Pathological stage at diagnosis (T2/T3 - see baseline characteristics) was compared to pathological stage of the surgical specimen at cystectomy. A response is considered as a decrease in T stage from T2/T3 seen at baseline to T1 or less indicating a reduction in tumour size/invasiveness. The T stage describes how far the primary tumour has spread. The higher the stage the further the tumour has grown through the bladder wall and into the surrounding tissues. The stages are Ta - non-invasive papillary carcinoma, Tis - flat non-invasive carcinoma, T1 - grown through the connective tissue but not into the muscle of the bladder wall, T2 - tumour has grown through the connective tissue and into the muscle of the bladder wall, T3 - tumour has grown through the muscle and into the fatty layer surrounding the bladder and T4 - the cancer has spread to surrounding tissues.

  Histological assessment of radical cystectomy specimen expected to be 15 weeks after commencing study chemotherapy.

Secondary Outcomes (12)

• Progression Free Survival at 5 Years After Cystectomy

  From registration up to 5 years after surgery

• Progression Free Survival of Patients Who Did Not Show Pathological Downstaging

  From registration up to 5 years after surgery

• Overall Survival at 5 Years After Cystectomy

  From registration up to 5 years after cystectomy

• Overall Survival of Patients Who Did Not Show Pathological Downstaging

  From registration up to 5 years after cystectomy

• Assessment of EQ-5D-5L Quality of Life

  Baseline, pre-Cycle 2 (each cycle was 21 days), pre-Cycle 3, pre-Cycle 4, and end of treatment visit (up to 13 weeks)

Study Arms (1)

Cabazitaxel + Cisplatin chemotherapy

EXPERIMENTAL

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

Interventions

Cabazitaxel + Cisplatin chemotherapy 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.

Also known as: Jevtana

Cabazitaxel + Cisplatin chemotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• ECOG Performance Status ≥ 2
• Lymph node involvement or metastatic disease
• Prior surgery (except transurethral resection of bladder tumour), radiation, chemotherapy, 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.

Sponsors & Collaborators

• University Hospitals Bristol and Weston NHS Foundation Trust: lead
• Sanofi: collaborator

Study Sites (1)

Bristol Haematology + Oncology Centre, Horfield Road

Bristol, BS2 8ED, United Kingdom

Location

Related Publications (1)

• Challapalli A, Masson S, White P, Dailami N, Pearson S, Rowe E, Koupparis A, Oxley J, Abdelaziz A, Ash-Miles J, Bravo A, Foulstone E, Perks C, Holly J, Persad R, Bahl A. A Single-arm Phase II Trial of Neoadjuvant Cabazitaxel and Cisplatin Chemotherapy for Muscle-Invasive Transitional Cell Carcinoma of the Urinary Bladder. Clin Genitourin Cancer. 2021 Aug;19(4):325-332. doi: 10.1016/j.clgc.2021.02.001. Epub 2021 Feb 18.

  PMID: 33727028 RESULT

MeSH Terms

Conditions

Urinary Bladder Neoplasms; Carcinoma, Transitional Cell

Interventions

cabazitaxel

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Results Point of Contact

• Title: Prof Amit Bahl
• Organization: University Hospitals Bristol and Weston NHS Foundation Trust

amit.bahl@uhbw.nhs.uk

+44 117 342 6733

Study Officials

• Amit K Bahl

  University Hospitals Bristol and Weston NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 17, 2012
• First Posted: June 12, 2012
• Study Start: July 25, 2012
• Primary Completion: November 1, 2017
• Study Completion: January 4, 2023
• Last Updated: March 6, 2026
• Results First Posted: March 6, 2026

Record last verified: 2025-12

Locations

GB (1)