Bristol Bladder Trial

• Research type

  Research Study

• Full title

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

• IRAS ID

  87941

• Contact name

  Amit Bahl

• Sponsor organisation

  University Hospitals Bristol NHS Foundation Trust Research and Innovation Department

• Eudract number

  2011-004090-82

• Research summary

  This is a phase 2 study, of 26 patients undergoing radical (curative) treatment for invasive bladder cancer. Its aim is to evaluate the proportion of patients whose disease responds to a new combination of chemotherapy drugs (Cisplatin and Cabazitaxel) given before surgery to remove the bladder. Some patients with bladder cancer are cured with existing treatments, but a proportion will develop persistent or recurrent cancer which can spread to other parts of the body. The existing standard treatment is chemotherapy with cisplatin, in combination with one or more other chemotherapy drugs, before surgery. Chemotherapy has been shown in large studies to improve life expectancy and long term cure rate, albeit by a small amount. However, it is not clear which drug or drugs are the most effective in combination with cisplatin. Cabazitaxel is a chemotherapy which improves survival in other cancers, even in advanced stages. It belongs to a drug family, taxanes, several of which can be effective treatments for invasive bladder cancer. Cabazitaxel has been studied in combination with Cisplatin in cancer patients and the doses being used in this trial are known to be safe. There is no reason to suspect that this combination would be less effective than existing treatments. It is hoped that this will lead to a larger Phase 3 trial, which will establish whether cabazitaxel and cisplatin are better than existing standard chemotherapy. Patients in this chemotherapy trial will also be offered 3 MRI scans and 5 blood tests to measure circulating tumour cells (CTCs) before and during their chemotherapy, with the aim of assessing whether MRI and/or CTC measurement are useful tools for predicting which patients will respond well to chemotherapy. MRI scans and CTC blood tests are optional and comprise two sub studies of the main trial.

• REC name

  South West - Central Bristol Research Ethics Committee

• REC reference

  11/SW/0345

• Date of REC Opinion

  6 Feb 2012

• REC opinion

  Further Information Favourable Opinion