Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624001188527p
Ethics application status
Submitted, not yet approved
Date submitted
2/08/2024
Date registered
30/09/2024
Date last updated
30/09/2024
Date data sharing statement initially provided
30/09/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
G-DISCO: A Phase 1 study of feasibility, safety and tolerability of synchronous intravesical administration of gemcitabine and docetaxel - ANZUP 2403.
Scientific title
G-DISCO: A Phase 1 study of feasibility, safety and tolerability of synchronous intravesical administration of gemcitabine and docetaxel - ANZUP 2403.
Secondary ID [1] 312640 0
ANZUP 2403
Universal Trial Number (UTN)
Trial acronym
G-DISCO
Linked study record

Health condition
Health condition(s) or problem(s) studied:
High risk non muscle invasive bladder cancer 334606 0
Condition category
Condition code
Cancer 331191 331191 0 0
Bladder

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 329157 0
Treatment: Drugs
Comparator / control treatment
This is a single arm trial with no comparator or control arm.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 339002 0
Feasibility of synchronous administration of intravesical gemcitabine and docetaxel
Timepoint [1] 339002 0
At completion of six weekly treatment regime

Primary outcome [2] 339249 0
Safety of synchronous administration of intravesical gemcitabine and docetaxel
Timepoint [2] 339249 0
Weekly assessment of adverse events over the six week treatment regime
Primary outcome [3] 339250 0
Tolerability of synchronous administration of intravesical gemcitabine and docetaxel
Timepoint [3] 339250 0
Weekly assessment over the six week treatment regime
Secondary outcome [1] 438243 0
Recurrence rates at 3 months
Timepoint [1] 438243 0
Three months after commencement of treatment
Secondary outcome [2] 439239 0
Carbon footprint - comparison of synchronous verses sequential administration of combination intravesical chemotherapy
Timepoint [2] 439239 0
At completion of six week treatment regime
Secondary outcome [3] 439244 0
Translational sub-study:

Pharmacokinetics of systemic absorption of gemcitabine and docetaxel
Timepoint [3] 439244 0
Pharmacokinetic analysis - blood sample collected one hour after synchronous administration of gemcitabine and docetaxel. Blood sample will be collected after the first weekly treatment.
Secondary outcome [4] 439662 0
Tolerability of synchronous administration of intravesical gemcitabine and docetaxel - this is an additional primary outcome
Timepoint [4] 439662 0
Weekly for the duration of the six weekly treatment regime
Secondary outcome [5] 439663 0
Translational sub-study:

Sub-typing of archival bladder tissue into luminal vs basal groups for correlation against response rates
Timepoint [5] 439663 0
Tumour subtyping - at completion of study - three months after completion of six weekly treatment instillations

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
28/10/2024
Actual
Date of last participant enrolment
Anticipated
26/10/2026
Actual
Date of last data collection
Anticipated
31/03/2027
Actual
Sample size
Target
15
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 317073 0
Other Collaborative groups
Name [1] 317073 0
Australian and New Zealand Urogenital and Prostate (ANZUP) Cancer Trials Group
Country [1] 317073 0
Australia
Primary sponsor type
Government body
Name
South Metropolitan Health Service
Address
Country
Australia
Secondary sponsor category [1] 319365 0
None
Name [1] 319365 0
Address [1] 319365 0
Country [1] 319365 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 315822 0
South Metropolitan Health Service Human Research Ethics Committee
Ethics committee address [1] 315822 0
Ethics committee country [1] 315822 0
Australia
Date submitted for ethics approval [1] 315822 0
30/07/2024
Approval date [1] 315822 0
Ethics approval number [1] 315822 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 135914 0
Prof Dickon Hayne
Address 135914 0
Fiona Stanley Hospital , 11 Robin Warren Drive, Murdoch WA 6150
Country 135914 0
Australia
Phone 135914 0
+61 08 6152 1130
Fax 135914 0
Email 135914 0
dickon.hayne@uwa.edu.au
Contact person for public queries
Name 135915 0
Cynthia Hawks
Address 135915 0
Fiona Stanley Hospital, 11 Robin Warren Drive, Murdoch WA 6150
Country 135915 0
Australia
Phone 135915 0
+61 08 6151 1139
Fax 135915 0
Email 135915 0
Cynthia.Hawks@health.wa.gov.au
Contact person for scientific queries
Name 135916 0
Dickon Hayne
Address 135916 0
Fiona Stanley Hospital. 11 Robin Warren Drive, Murdoch WA 6150
Country 135916 0
Australia
Phone 135916 0
+61 08 6152 1130
Fax 135916 0
Email 135916 0
dickon.hayne@uwa.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.