None listed
Conditions
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. Who is it for? Participants are eligible for this study if they are over the age of 18 with confirmed fully resected, high-risk, non-muscle-invasive bladder cancer where BCG treatment has been unsuccessful or cannot be given. Study details Participants will undergo synchronous intravesical administration of gemcitabine and docetaxel. The planned treatment schedule is once a week for six weeks. Participants will then be tested weekly for completion, adverse events, patient-reported outcome, and 3 months recurrence. Translational studies on a small sample of blood collected after the first weekly treatment and on existing bladder tumour specimens will be performed if consent is given. It is hoped that findings from this study will help improve the health outcomes for people with high risk non muscle invasive bladder cancer by providing an alternative treatment option to removal of the bladder when BCG is unsuccessful or cannot be given.
Interventions
Participants will undergo synchronous intravesical administration of gemcitabine and docetaxel for treatment of high risk non muscle invasive bladder cancer.
Participants will be administered 1g gemcitabine and 37.5mg of docetaxel constituted together in 50mls of saline for a minimum recommended dwell time of 60 minutes and optimum dwell time of 90 minutes.
Participants will undergo the synchronous administration of gemcitabine and docetaxel at the Day Procedure Unit, under the care of Uro
Participants will undergo synchronous intravesical administration of gemcitabine and docetaxel for treatment of high risk non muscle invasive bladder cancer. Participants will be administered 1g gemcitabine and 37.5mg of docetaxel constituted together in 50mls of saline for a minimum recommended dwell time of 60 minutes and optimum dwell time of 90 minutes. Participants will undergo the synchronous administration of gemcitabine and docetaxel at the Day Procedure Unit, under the care of Urology. This treatment regime will be administered by nursing staff once a week for six weeks. Participants will remain in the Day Procedure Unit for the duration of the dwell time (between 60 and 90 minutes) and will remain under the observation of Day Procedure Unit nursing staff. At the completion of the dwell time participants will void in the Day Procedure Unit before leaving.
Sponsors
South Metropolitan Health Service
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Inclusion Criteria: 1. Fully resected, high-risk, non-muscle-invasive bladder cancer (HRNMIBC) - (carcinoma in situ (CIS) allowed)) 2. Disease unresponsive to intravesical therapy, to include: a) Bacille Calmette-Guerin (BCG) unresponsive disease* despite adequate** BCG therapy b) HRNMIBC where BCG is contra-indicated or unsuitable c) Unresponsive disease to prior intra-vesical chemotherapy in patients where BCG is either unsuitable or unavailable d) Persistent or recurrent high-grade disease after a less than adequate course of intravesical therapy, in patients considered not suitable for further intravesical therapy 3. Unsuitable for, or patient declining, radical cystectomy 4. Age 18 years and over 5. Eastern Cooperative Oncology Group (ECOG) performance status 0 – 2 6. Life expectancy > 6 months 7. Adequate organ and bone marrow 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.
Exclusion criteria
Exclusion Criteria: 1. Any unresolved toxicity National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Grade equal to or greater than 2 from previous anti-cancer therapy 2. History of allogenic organ transplantation 3. Current or prior documented autoimmune or inflammatory disorders 4. History of another primary malignancy within the last 5 years, excluding non-melanomatous skin cancer 5. History of active primary immunodeficiency 6. Active tuberculosis, hepatitis b, or hepatitis c 7. Current use of immunosuppressive medications 8. Female patients who are pregnant or breastfeeding, or male or female patients who are not willing to employ effective birth control during treatment
Outcome results
None listed