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Trial registered on ANZCTR


Registration number
ACTRN12607000160437
Ethics application status
Approved
Date submitted
7/03/2006
Date registered
7/03/2007
Date last updated
7/03/2007
Type of registration
Retrospectively registered

Titles & IDs
Public title
Intravesical Gemcitabine
Scientific title
A Phase ll trial to measure the response rate (Rate of recurrence following treatment) ,toxicity and safety of weekly intravesical gemcitabine in patients with transitional cell carcinoma of the bladder.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Superficial Bladder Cancer 1662 0
Condition category
Condition code
Cancer 1767 1767 0 0
Bladder

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intravesical gemcitabine 2g weekly for 6 weeks
Intervention code [1] 932 0
Treatment: Drugs
Comparator / control treatment
No comparator.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 2474 0
To determine the response rate of intravesical gemcitabine in patients with transitional cell carcinoma of the bladder (Rate of recurrence following treatment)
Timepoint [1] 2474 0
Three monthly cystoscopies +/- biopsy for one year following initial treatment.
Secondary outcome [1] 4239 0
To determine the toxicity and safety of weekly intravesical gemcitabine gemcitabine.
Timepoint [1] 4239 0
For 6 weeks during the intervention.
Secondary outcome [2] 4240 0
To determine the systemic exposure of gemcitabine when given by an intravesical route with weekly haematology, erythrocyte sedimentation rate (ESR) and C reactive protein (CRP) for 8 weeks and liver function tets (LFTs) and biochemistry (UECs) fortnightly during treatment.
Timepoint [2] 4240 0
Secondary outcome [3] 4241 0
Vital signs
Timepoint [3] 4241 0
Recorded weekly pre and post treatment.
Secondary outcome [4] 4242 0
Toxicity and safety
Timepoint [4] 4242 0
Assessed at a clinic visit after the third and sixth treatment and laboratory tests (the weekly blood tests for 8 weeks).
Secondary outcome [5] 4243 0
Pharmacokinetic blood samples
Timepoint [5] 4243 0
Obtained prior to intravesical treatment , then at 30, 60, 90, 120 and 180 minutes after the start of the first instillation of gemcitabine only.

Eligibility
Key inclusion criteria
Patients must have either i) newly diagnosed superficial transitional cell carcinoma of the bladder, up to G3cT1, previously untreated by intravesical chemotherapy (Group A), or,ii) recurrent superficial transitional cell carcinoma of the bladder after at least one previous course of intravesical Bacillus Calmette-Guerin (BCG) or Mitomycin (Group B). At least 12 weeks must have elapsed since the last BCG or Mitomycin treatment.• Pathologic or cytologic confirmation of transitional cell carcinoma. • Males or females are eligible Karnofsky Performance Status (KPS) >70% • Adequate marrow function defined as neutrophils > 1.5x109/l and platelets >100 x109/l• Adequate hepatic function defined as total bilirubin < 1.5 x normal and aspartate aminotransferase (AST), alanine aminotransferase (ALT) < 3 times normal• Informed consent.
Minimum age
18 Years
Maximum age
Not stated
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Prior radiation to the bladder. Previous radiation to other sites in the pelvis (eg. Prostate) is allowed, provided no more than 25% of the pelvis was included in the radiation (RT) field, and all side effects from RT have resolved.• Muscle invasive disease at baseline cystoscopy• Untreated urinary tract infection or abscess within the previous 7 days• Other concerns that in the opinion of the investigator, would make it difficult or unethical for a patient to undergo intravesical treatment within approximately 6 weeks of baseline cystoscopy

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 2
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1920 0
Commercial sector/Industry
Name [1] 1920 0
Eli Lilly Australia
Address [1] 1920 0
Country [1] 1920 0
Australia
Primary sponsor type
Hospital
Name
St George Hospital, Kogarah
Address
Country
Australia
Secondary sponsor category [1] 1731 0
None
Name [1] 1731 0
N/A
Address [1] 1731 0
Country [1] 1731 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3567 0
St George Public Hospita
Ethics committee address [1] 3567 0
Ethics committee country [1] 3567 0
Australia
Date submitted for ethics approval [1] 3567 0
Approval date [1] 3567 0
24/02/2004
Ethics approval number [1] 3567 0
Ethics committee name [2] 3568 0
St George Public Hospital
Ethics committee address [2] 3568 0
Ethics committee country [2] 3568 0
Australia
Date submitted for ethics approval [2] 3568 0
Approval date [2] 3568 0
29/06/2004
Ethics approval number [2] 3568 0
Ethics committee name [3] 3569 0
St George Private Hospital
Ethics committee address [3] 3569 0
Ethics committee country [3] 3569 0
Australia
Date submitted for ethics approval [3] 3569 0
Approval date [3] 3569 0
29/06/2004
Ethics approval number [3] 3569 0
Ethics committee name [4] 3570 0
Port Macquarie Base Hospital
Ethics committee address [4] 3570 0
Ethics committee country [4] 3570 0
Australia
Date submitted for ethics approval [4] 3570 0
Approval date [4] 3570 0
11/10/2004
Ethics approval number [4] 3570 0
Ethics committee name [5] 3571 0
Liverpool Hospital
Ethics committee address [5] 3571 0
Ethics committee country [5] 3571 0
Australia
Date submitted for ethics approval [5] 3571 0
Approval date [5] 3571 0
01/08/2005
Ethics approval number [5] 3571 0
Ethics committee name [6] 3572 0
St George Public Hospital
Ethics committee address [6] 3572 0
Ethics committee country [6] 3572 0
Australia
Date submitted for ethics approval [6] 3572 0
Approval date [6] 3572 0
27/09/2005
Ethics approval number [6] 3572 0
Ethics committee name [7] 3573 0
St George Private Hospital
Ethics committee address [7] 3573 0
Ethics committee country [7] 3573 0
Australia
Date submitted for ethics approval [7] 3573 0
Approval date [7] 3573 0
27/09/2005
Ethics approval number [7] 3573 0
Ethics committee name [8] 3574 0
Liverpool Hospital
Ethics committee address [8] 3574 0
Ethics committee country [8] 3574 0
Australia
Date submitted for ethics approval [8] 3574 0
Approval date [8] 3574 0
24/10/2005
Ethics approval number [8] 3574 0

Summary
Brief summary
The treatment for recurrent bladder tumour following trans-urethral resection (TUR) continues to be problematic. This protocol is a phase ll trial of gemcitabine directly instilled into the bladder of patients with transitional cell carcinoma who have undergone a standard TUR. The objectives of the study are to determine if intravesical gemcitabine is capable of reducing the rate of tumour recurrence in the bladder. Patients with transitional cell carcinoma who are at risk of recurrence following TUR, or who have failed previous standard treatment with intravesical BCG are eligible for the study. Patients will receive weekly bladder instillation of 2000mg of gemcitabine via a catheter, followed by re-evaluation of disease at 3 months by the urologist. Toxicity is expected to be minimal. The results of this trial will allow a phase lll trial comparing intravesical gemcitabine with BCG or mitomycin C to be undertaken.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35518 0
Address 35518 0
Country 35518 0
Phone 35518 0
Fax 35518 0
Email 35518 0
Contact person for public queries
Name 10121 0
Linda O'Malley
Address 10121 0
Clinical Trials Unit
Cancer Centre
St George Hospital
Gray Street
Kogarah NSW 2217
Country 10121 0
Australia
Phone 10121 0
+61 2 93501920
Fax 10121 0
+61 2 93503958
Email 10121 0
Linda.O'Malley@sesiahs.health.nsw.gov.au
Contact person for scientific queries
Name 1049 0
Dr. Paul de Souza
Address 1049 0
Cancer Centre
St George Hospital
Gray Street
Kogarah NSW 2217
Country 1049 0
Australia
Phone 1049 0
+61 2 93503910
Fax 1049 0
+61 2 93503910
Email 1049 0
Paul.deSouza@SESIAHS.HEALTH.NSW.GOV.AU

No information has been provided regarding IPD availability
Summary results
No Results