A Phase II Study Of ZD1839 (NSC #715055) In Renal Cell Carcinoma Stage IV And Renal Cell Carcinoma Recurrent
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.
Interventional
Primary Purpose: Treatment
Nancy A. Dawson, MD
Study Chair
University of Maryland Greenebaum Cancer Center
United States: Food and Drug Administration
CDR0000068512
NCT00014183
January 2001
August 2005
Name | Location |
---|---|
Marlene & Stewart Greenebaum Cancer Center, University of Maryland | Baltimore, Maryland 21201 |
Veterans Affairs Medical Center - Baltimore | Baltimore, Maryland 21201 |