Brief Summary
The purpose of this project is to assess the feasibility, safety and tolerability of synchronous intravesical instillation of gemcitabine and docetaxel for this cohort of patients.
Intervention/Treatment
- Drug: Gemcitabine.
- Drug: Docetaxel.
Inclusion Criteria:
- Fully resected, high-risk, non-muscle-invasive bladdera hollow, muscular sac in the pelvis that stores urine cancera disease where abnormal cells split without control and spread to other nearby body tissue and/or organs (HRNMIBC) – (carcinoma in situpre-cancerous condition where abnormal cells haven't spread beyond the place they developed (CIS) allowed)).
- Disease unresponsive to intravesical therapy, to include:
- Bacille Calmette-Guerin (BCG) unresponsive disease* despite adequate** BCG therapy.
- HRNMIBC where BCG is contra-indicated or unsuitable.
- Unresponsive disease to prior intra-vesical chemotherapya cancer treatment that uses drugs to kill or slow the growth of cancer cells, while minimising damage to healthy cells in patients where BCG is either unsuitable or unavailable.
- Persistent or recurrent high-grade disease after a less than adequate course of intravesical therapy, in patients considered not suitable for further intravesical therapy.
- Unsuitable for, or patient declining, radical cystectomycomplete or partial removal of the bladder.
- Age 18 years and over.
- Eastern Cooperative Oncologythe study, diagnosis and treatment of cancer Group (ECOG) performance status 0 – 2.
- Life expectancy > 6 months.
- Adequate organ and bone marrowsoft, spongy tissue found in bones that makes blood cells function.
*BCG-unresponsive disease – is defined as at least one of:
i. Persistent or recurrent CIS +/- Ta/1 within 12 months of completion of adequate BCG therapy
ii. Recurrent high-grade Ta/1 within 6 months of completion of adequate BCG therapy
iii. High-grade T1 at the first evaluation following an induction BCG course
**An adequate BCG course – is defined as at least five doses of an induction course, plus at least two further doses (maintenance or second induction) of BCG. This definition applies regardless of issues relating to BCG timing, dosing, and strain.