Below the Belt Award

This project is a Phase 1 investigator led project. Phase 1 studies are small studies that help determine if a new treatment is safe. This project is investigating a new method of giving combination intravesical chemotherapy (putting, or instilling, the drugs directly into the bladder via a catheter) to patients with high risk non-muscle invasive bladder cancer (HRNMIBC). The treatment will be in patients where the cancer returned despite the usual first line therapy into the bladder with Bacille Calmette Guérin (BCG) (the current first line “gold standard” treatment) or in those who can’t have BCG. Current usual practice is to give two chemotherapies, gemcitabine and then docetaxel, one after the other. Gemcitabine is put in first then left in for two hours. It is then drained out and docetaxel put in and left for a further two hours, the whole process taking near to 5 hours. This project will assess the safety, tolerability and feasibility of synchronous administration of intravesical gemcitabine and docetaxel. Both agents will be instilled into the bladder together and will then remain together in the bladder for the recommended dwell time of two hours. This project will record Patient Reported Outcomes (PRO’s), side effects, the rate of completing 6 treatments given weekly, and cancer recurrence rates. At the completion of this 6-week induction regime patients will undergo a cystoscopy (camera into the bladder) under general anaesthetic and bladder biopsies will be taken which is the standard practice after intra-vesical chemotherapy.