Bladder Cancer Clinical Trial
Official title:
Evaluation of ZD1839 (NSC #715055) for Advanced Transitional Cell Carcinoma of the Urothelium, Phase II
RATIONALE: Biological therapies such as ZD 1839 may interfere with the growth of the tumor
cells and slow the growth of cancer of the urinary tract.
PURPOSE: Phase II trial to study the effectiveness of ZD 1839 in treating patients who have
advanced cancer of the urinary tract.
OBJECTIVES:
- Determine the 6-month progression-free survival rate of patients with advanced
transitional cell carcinoma of the urothelium treated with ZD 1839.
- Determine the overall survival and response (confirmed complete and partial response)
in these patients treated with this regimen.
- Determine the qualitative and quantitative toxicity of this regimen in these patients.
- Evaluate the changes in growth factor protein kinase expression before and after
treatment and at the time of disease progression in these patients treated with this
regimen.
OUTLINE: Patients receive oral ZD 1839 once daily. Treatment continues in the absence of
disease progression or unacceptable toxicity.
Patients are followed every 3 months for 1 year and then every 6 months for 2 years.
PROJECTED ACCRUAL: A total of 30-55 patients will be accrued for this study.
;
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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