None listed
Conditions
Brief summary
G-DISCOTEQ is testing how well two cancer drugs (Gemcitabine and Docetaxel) work when they are given directly into the bladder at the same time. Who is it for? You may be eligible for this study if you are a male or female age 18 or above with either carcinoma in situ with or without papillary tumours or papillary tumours. Study details Participants will receive intravesical chemotherapy consisting of Gemcitabine (1 g) and Docetaxel (37.5 mg) combined in 50 mL of saline per instillation. Treatment begins with an induction phase of weekly instillations for six weeks, followed by a maintenance phase of monthly instillations for ten months. After the intervention, participants will undergo cystoscopy, cytology, and biopsy. Medical records will be reviewed to evaluate key outcomes, including complete response rate, recurrence-free survival, progression-free survival, cystectomy-free survival, cancer-specific survival, overall survival, and safety. Quality of life will also be assessed through patient-reported outcome measures. It is hoped that the results from this study will contribute to the field of non-muscle-invasive bladder cancer.
Interventions
Cohort A: People with carcinoma in situ with or without papillary tumours.
Cohort B: People with papillary tumours.
Both cohorts will receive the same intervention:
Intravesical synchronous CO-administration of Gemcitabine-Docetaxel
1g gemcitabine and 37.5mg of docetaxel constituted together in 50 mL of saline per instillation
Induction phase: Weekly treatments for 6 weeks
Maintenance phase: Monthly treatments for 10 months.
Sponsors
South Metropolitan Health Service
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Cohort A: Fully resected high-risk NMIBC (CIS with or without concurrent high-grade Ta/T1 papillary disease). Cohort B: Fully resected high-risk NMIBC (papillary tumours (high-grade Ta or any-grade T1) without CIS). 2. The most recent cystoscopy or TURBT must have been done within 12 weeks before study enrolment 3. BCG-unresponsive disease * despite adequate BCG therapy **. 4. Ineligible for, or unwilling to undergo radical cystectomy. 5. Age greater than or equal to 18 years. 6. Eastern Cooperative Oncology Group (ECOG) performance status 0-2. 7. Life expectancy greater than 6 months. 8. Adequate organ and marrow function as defined below: i. Haemoglobin greater than or equal to 90 g/L ii. Absolute neutrophil count (ANC) greater than or equal to 1.0 × 109 /L iii. Platelet count greater than or equal to 100 × 109/L iv. Total bilirubin less than or equal to 1.5 x institutional upper limit of normal (ULN). v. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) less than or equal to 2.5 x institutional ULN *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
1. History or concurrent stage T2 or greater urothelial cancer. 2. History or concurrent urothelial carcinoma of the upper urinary tract. 3. History or concurrent variant bladder cancer histology less than or equal to 25%. 4. Prior radiotherapy of the pelvis. 5. History of another primary malignancy within the last 5 years, excluding nonmelanoma skin cancer and ISUP grade group 1 prostate cancer. 6. Known hypersensitivity reaction to any component of docetaxel and/or gemcitabine. 7. Myocardial infarction within 6 months of enrolment. 8. Receipt of live attenuated vaccine within 30 days prior to administration of any dose 9. 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