Bladder Cancer Clinical Trial
Official title:
Phase II Study of Intravesical Gemcitabine in Patients With Superficial Bladder Cancer Who Have Progressed Despite Intravesical BCG
RATIONALE: Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop
the growth of tumor cells, either by killing the cells or by stopping them from dividing.
Giving gemcitabine directly into the bladder may kill more tumor cells.
PURPOSE: This phase II trial is studying how well gemcitabine works in treating patients
with recurrent bladder cancer that has progressed despite previous Bacillus Calmette-Guerin
(BCG).
OBJECTIVES:
- Determine the 8-12 week efficacy of intravesical gemcitabine, in terms of complete
response rate, in patients with recurrent superficial transitional cell carcinoma of
the bladder that have progressed despite prior intravesical Bacillus Calmette-Guerin
(BCG).
- Determine the recurrence-free, worsening-free, progression-free, and overall survival
of patients treated with this drug.
- Evaluate the toxicity of this drug in these patients.
- Correlate, preliminarily, expression levels of genes or genetic polymorphisms involved
in the gemcitabine pathway and angiogenesis with clinical toxicity, response, and
relapse-free survival of patients treated with this drug.
OUTLINE: This is a multicenter study.
- Induction therapy: Patients receive gemcitabine intravesically once a week for 6 weeks
(weeks 1-6) in the absence of disease progression or unacceptable toxicity. Patients
achieving a complete response proceed to maintenance therapy at week 14.
- Maintenance therapy: Patients receive gemcitabine intravesically once in weeks 14, 18,
22, 26, 30, 34, 38, 42, 46, and 50 in the absence of disease progression or
unacceptable toxicity.
After completion of study treatment, patients are followed every 3 months for 2 years and
then every 6 months for 3 years.
PROJECTED ACCRUAL: A total of 25-45 patients will be accrued for this study within 6-12
months.
;
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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