Intravesical Gemcitabine
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.
St George Hospital, Kogarah
90 participants
Jan 1, 2005
Interventional
Conditions
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.
Eligibility
Plain Language Summary
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Interventions
Intravesical gemcitabine 2g weekly for 6 weeks
Locations(1)
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ACTRN12607000160437