RecruitingPhase 2ACTRN12607000160437

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.


Sponsor

St George Hospital, Kogarah

Enrollment

90 participants

Start Date

Jan 1, 2005

Study Type

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

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This study is for people with superficial bladder cancer (cancer that has not yet grown deep into the bladder wall). It tests whether a drug called gemcitabine, delivered directly into the bladder through a catheter (a tube) once a week, can prevent the cancer from coming back after it has been surgically removed. The study is open to people with newly diagnosed bladder cancer as well as those whose cancer has come back after previous treatment with BCG or mitomycin. You may be eligible if: - You are 18 years of age or older - You have superficial transitional cell carcinoma of the bladder confirmed by tissue or cell sample - You have either newly diagnosed bladder cancer not previously treated with bladder washes, OR cancer that has come back after at least one course of BCG or Mitomycin (with at least 12 weeks since the last treatment) - Your general health and blood counts are within required levels You may NOT be eligible if: - You have previously had radiation treatment to the bladder - Your cancer has grown into the muscle of the bladder - You have a current urinary tract infection - You have other concerns that make bladder treatment unsafe at this time Talk to your doctor about whether this trial might be right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Intravesical gemcitabine 2g weekly for 6 weeks

Intravesical gemcitabine 2g weekly for 6 weeks


Locations(1)

Australia

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ACTRN12607000160437


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