Kidney Cancer Clinical Trial
Official title:
A Phase II Study Of ZD1839 (NSC #715055) In Renal Cell Carcinoma Stage IV And Renal Cell Carcinoma Recurrent
RATIONALE: Biological therapies such as ZD 1839 may interfere with the growth of the tumor
cells and slow the growth of kidney cancer.
PURPOSE: Phase II trial to study the effectiveness of ZD 1839 in treating patients who have
recurrent or stage IV kidney cancer.
OBJECTIVES:
- Determine the response rate in patients with progressive stage IV or recurrent renal
cell cancer treated with ZD 1839.
- Determine the median time to objective progression in these patients receiving this
drug.
- Determine the toxic effects of this drug in this patient population.
- Determine if epidermal growth factor receptor expression in tumor tissue correlates with
response and survival of these patients.
OUTLINE: This is a multicenter study.
Patients receive oral ZD 1839 daily. Courses repeat every 28 days in the absence of disease
progression or unacceptable toxicity.
Patients are followed every 8 weeks.
PROJECTED ACCRUAL: A total of 21-45 patients will be accrued for this study within 11-23
months.
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