Evaluation of ZD1839 (NSC #715055) for Advanced Transitional Cell Carcinoma of the Urothelium, Phase II
Overview
- Phase
- Phase 2
- Intervention
- gefitinib
- Conditions
- Bladder Cancer
- Sponsor
- SWOG Cancer Research Network
- Enrollment
- 31
- Locations
- 95
- Primary Endpoint
- Progression-free survival rate
- Status
- Completed
- Last Updated
- 13 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
ZD 1839
Intervention: gefitinib
Outcomes
Primary Outcomes
Progression-free survival rate
Time Frame: From date of registration until progression or death from any cause, whichever came first, assessed up to 3 years
Secondary Outcomes
- Overall survival(From date of registration until progression or death from any cause, whichever came first, assessed up to 3 years)
- Confirmed complete and partial response to ZD 1839(From date of registration to progression or death from any cause, whichever came first, assessed up to 3 years)
- Number and grade of adverse events to ZD 1839(From date of registration to progression or death from any cause, whichever came first, assessed up to 3 years)