Back to resultsBristol Bladder Trial
Primary Purpose
Infiltrating Bladder Urothelial Carcinoma
Status
Unknown status
Phase
Phase 2
Locations
United Kingdom
Study Type
Interventional
Intervention
Cabazitaxel + Cisplatin chemotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Infiltrating Bladder Urothelial Carcinoma focused on measuring Bladder cancer, Transitional cell carcinoma, Urothelial cancer, Cisplatin, Cabazitaxel, Chemotherapy, Neo adjuvant chemotherapy
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.
Sites / Locations
- Bristol Haematology + Oncology Centre, Horfield Road
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Cabazitaxel + Cisplatin chemotherapy
Arm Description
Cabazitaxel 15mg/m2 Intravenous (IV)followed by Cisplatin 70mg/m2 IV on day 1 of each 21 day cycle for 4 cycles
Outcomes
Primary Outcome Measures
Overall pathological response rate
Secondary Outcome Measures
To record progression free survival
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
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
Common toxicity criteria adverse events (CTC AE ) Version 4.03 will be assessed at baseline and following each cycle of chemotherapy
Overall survival
From the date of registration to the date of death from any cause.
Full Information
NCT ID
NCT01616875
First Posted
May 17, 2012
Last Updated
November 11, 2020
Sponsor
University Hospitals Bristol and Weston NHS Foundation Trust
Collaborators
Sanofi
1. Study Identification
Unique Protocol Identification Number
NCT01616875
Brief Title
Bristol Bladder Trial
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 Type
Interventional
2. Study Status
Record Verification Date
May 2019
Overall Recruitment Status
Unknown status
Study Start Date
May 2012 (undefined)
Primary Completion Date
November 2017 (Actual)
Study Completion Date
January 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospitals Bristol and Weston NHS Foundation Trust
Collaborators
Sanofi
4. Oversight
Data Monitoring Committee
No
5. 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infiltrating Bladder Urothelial Carcinoma
Keywords
Bladder cancer, Transitional cell carcinoma, Urothelial cancer, Cisplatin, Cabazitaxel, Chemotherapy, Neo adjuvant chemotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
28 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cabazitaxel + Cisplatin chemotherapy
Arm Type
Experimental
Arm Description
Cabazitaxel 15mg/m2 Intravenous (IV)followed by Cisplatin 70mg/m2 IV on day 1 of each 21 day cycle for 4 cycles
Intervention Type
Drug
Intervention Name(s)
Cabazitaxel + Cisplatin chemotherapy
Other Intervention Name(s)
Jevtana
Intervention 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.
Primary Outcome Measure Information:
Title
Overall pathological response rate
Time Frame
Histological assessment of radical cystectomy specimen expected to be 15 weeks after commencing study chemotherapy
Secondary Outcome Measure Information:
Title
To record progression free survival
Description
From date of registration until the date of first documented progression or date of death from any cause whichever came first.
Time Frame
Up to 5 years following radical cystectomy
Title
To assess quality of life
Description
EQ-5D and EORTC QLQC30 and BLM30 will be assessed at baseline and following each cycle of chemotherapy
Time Frame
Up to 13 weeks from baseline
Title
To record side effects and tolerability of treatment
Description
Common toxicity criteria adverse events (CTC AE ) Version 4.03 will be assessed at baseline and following each cycle of chemotherapy
Time Frame
Up to 13 weeks from baseline
Title
Overall survival
Description
From the date of registration to the date of death from any cause.
Time Frame
Up to 5 years following radical cystectomy
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amit K Bahl
Organizational Affiliation
University Hospitals Bristol and Weston NHS Foundation Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bristol Haematology + Oncology Centre, Horfield Road
City
Bristol
ZIP/Postal Code
BS2 8ED
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
Bristol Bladder Trial
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