Vandetanib in non-cisplatin fit patients with urothelial cancers

• Research type

  Research Study

• Full title

  A randomised phase II Trial of carboplatin and gemcitabine +/- vandetanib in first line treatment Of advanced Urothelial cell Cancer in patients who are not suitable to receive cisplatin

• IRAS ID

  24975

• Sponsor organisation

  Cardiff University

• Eudract number

  2009-010140-33

• ISRCTN Number

  68146831

• Research summary

  In the UK, 5000 deaths per year occur due to advanced urothelial cancer. Usually, doctors treat patients with cisplatin and gemcitabine chemotherapy. Typically, 55% of patients will respond to this treatment. However, 4 in 10 patients are not suitable to receive cisplatin, and they are given carboplatin instead. Current UK trials are focused on improving the outcomes for patients having cisplatin, but there are no trials for those having carboplatin.Vandetanib is a new tablet which may help to slow down cancer growth and the growth of tumour blood vessels. It may also prevent tumours from spreading. There is evidence from laboratory studies that vandetanib may work in urothelial cancer. Trials in patients with other types of cancer have shown it is safe to combine vandetanib with carboplatin or gemcitabine.TOUCAN is a randomised phase II trial of carboplatin and gemcitabine vandetanib in first line treatment of advanced urothelial cell cancer in patients who are not suitable to receive cisplatin. The trial will recruit 122 eligible patients from across the UK and will assess whether adding vandetanib to carboplatin and gemcitabine improves the rate at which patients suffer disease deterioration or death. It will also show whether the side-effects of adding vandetanib to the current standard treatment are acceptable. All patients will receive up to six 21 day cycles of chemotherapy. In addition, half the patients will receive vandetanib; the rest will take a dummy (placebo) tablet. A computer will be used to randomly assign patients vandetanib or placebo. Neither the patient nor their doctor will know whether the patient is receiving vandetanib or placebo. If the 3-drug chemotherapy combination is shown to be more effective and tolerable it will be taken forward into a Phase III trial.

• REC name

  West of Scotland REC 1

• REC reference

  09/S0703/98

• Date of REC Opinion

  4 Sep 2009

• REC opinion

  Further Information Favourable Opinion