ACTRN12624001188527Not yet recruitingPhase 1
G-DISCO: A Phase 1 study of feasibility, safety and tolerability of synchronous intravesical administration of gemcitabine and docetaxel - ANZUP 2403.
South Metropolitan Health Service0 sites15 target enrollmentStarted: September 30, 2024Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Not yet recruiting
- Enrollment
- 15
- Primary Endpoint
- Feasibility of synchronous administration of intravesical gemcitabine and docetaxel[Completion rates of planned 6 week course of intravesical gemcitabine and docetaxel. Completion rates will be determined by review of patient electronic medical records. At completion of six weekly treatment regime <br><br>];Safety of synchronous administration of intravesical gemcitabine and docetaxel[Adverse event assessment using Common Terminology Criteria for Adverse Events (CTCAE) V5.0. <br><br>Known side effects of intravesical treatment are bladder inflammation (cystitis) and haematuria Weekly assessment of adverse events over the six week treatment regime];Tolerability of synchronous administration of intravesical gemcitabine and docetaxel[Patient reported outcome measures (PROM):<br> Non Muscle Invasive Bladder Cancer Symptom Index questionnaire (NMIBC-SI)<br> Weekly assessment over the six week treatment regime]
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Allocation
- Non-randomised trial
- Primary Purpose
- Treatment
- Masking
- Open (masking not used)
Eligibility Criteria
- Ages
- 18 Years to No limit (—)
- Sex
- All
Inclusion Criteria
- •Inclusion Criteria:1.Fully resected, high-risk, non-muscle-invasive bladder cancer (HRNMIBC) - (carcinoma in situ (CIS) allowed))
- •Disease unresponsive to intravesical therapy, to include:a) Bacille Calmette-Guerin (BCG) unresponsive disease* despite adequate** BCG therapyb) HRNMIBC where BCG is contra-indicated or unsuitablec) 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
- •Unsuitable for, or patient declining, radical cystectomy
- •Age 18 years and over
- •Eastern Cooperative Oncology Group (ECOG) performance status 0 –
- •Life expectancy > 6 months
- •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 therapyii. 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:
- •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
- •History of allogenic organ transplantation
- •Current or prior documented autoimmune or inflammatory disorders
- •History of another primary malignancy within the last 5 years, excluding non-melanomatous skin cancer
- •History of active primary immunodeficiency
- •Active tuberculosis, hepatitis b, or hepatitis c
- •Current use of immunosuppressive medications
- •Female patients who are pregnant or breastfeeding, or male or female patients who are not willing to employ effective birth control during treatment
Outcomes
Primary Outcomes
Feasibility of synchronous administration of intravesical gemcitabine and docetaxel[Completion rates of planned 6 week course of intravesical gemcitabine and docetaxel. Completion rates will be determined by review of patient electronic medical records. At completion of six weekly treatment regime <br><br>];Safety of synchronous administration of intravesical gemcitabine and docetaxel[Adverse event assessment using Common Terminology Criteria for Adverse Events (CTCAE) V5.0. <br><br>Known side effects of intravesical treatment are bladder inflammation (cystitis) and haematuria Weekly assessment of adverse events over the six week treatment regime];Tolerability of synchronous administration of intravesical gemcitabine and docetaxel[Patient reported outcome measures (PROM):<br> Non Muscle Invasive Bladder Cancer Symptom Index questionnaire (NMIBC-SI)<br> Weekly assessment over the six week treatment regime]
Secondary Outcomes
No secondary outcomes reported
Investigators
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