Bristol Bladder Trial
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
|Infiltrating Bladder Urothelial Carcinoma||Drug: Cabazitaxel + Cisplatin chemotherapy||Phase 2|
|Study Design:||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|
- Overall pathological response rate [ Time Frame: Histological assessment of radical cystectomy specimen expected to be 15 weeks after commencing study chemotherapy ]
- To record progression free survival [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Up to 5 years following radical cystectomy ]From the date of registration to the date of death from any cause.
|Study Start Date:||May 2012|
|Estimated Study Completion Date:||January 2018|
|Estimated Primary Completion Date:||September 2017 (Final data collection date for primary outcome measure)|
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 Name: Jevtana
Please refer to this study by its ClinicalTrials.gov identifier: NCT01616875
|Contact: Amit Bahl||0117 342 email@example.com|
|Contact: Susan Masson||0117 342 firstname.lastname@example.org|
|Bristol Haematology + Oncology Centre, Horfield Road||Recruiting|
|Bristol, United Kingdom, BS2 8ED|
|Contact: Sylvia Pearson 0117 3424263 email@example.com|
|Contact: Seonaid Wright 0117 342 2069 firstname.lastname@example.org|
|Principal Investigator: Amit K Bahl|
|Sub-Investigator: Susan Masson|
|Principal Investigator:||Amit K Bahl||University Hospitals Bristol NHS Foundation Trust|