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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
31
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
Overall survival
Time frame: 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
Time frame: 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
Time frame: From date of registration to progression or death from any cause, whichever came first, assessed up to 3 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
University of Alabama at Birmingham Comprehensive Cancer Center
Birmingham, Alabama, United States
MBCCOP - Gulf Coast
Mobile, Alabama, United States
CCOP - Greater Phoenix
Phoenix, Arizona, United States
Veterans Affairs Medical Center - Phoenix (Hayden)
Phoenix, Arizona, United States
Veterans Affairs Medical Center - Tucson
Tucson, Arizona, United States
Arizona Cancer Center
Tucson, Arizona, United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States
Veterans Affairs Medical Center - Little Rock (McClellan)
Little Rock, Arkansas, United States
Cancer Center and Beckman Research Institute, City of Hope
Duarte, California, United States
Veterans Affairs Medical Center - Long Beach
Long Beach, California, United States
...and 85 more locations