Phase II Trial of ZD1839 (IRESSA®) and Pegylated Interferon Alfa 2b (PEG-Intron™) in Unresectable or Metastatic Renal Cell Carcinoma
- Determine the 6-month progression-free survival of patients with unresectable or
metastatic renal cell carcinoma treated with gefitinib and PEG-interferon alfa-2b.
- Determine the response rate (by RECIST criteria), duration of response, time to
treatment failure, and overall survival of patients treated with this regimen.
- Assess toxicity and tolerability of this regimen in these patients.
- Determine the pre-treatment expression of the von Hippel-Lindau (VHL) protein, the
epidermal growth factor receptor (EGFR), and p27, and correlate with response to
- Determine post-treatment alteration of EGFR and p27 expression in patients with tumors
accessible for serial biopsy.
- Assess changes in EGFR levels in buccal epithelial cells in patients treated with this
OUTLINE: This is a multicenter study.
Patients receive oral gefitinib once daily and PEG-interferon alfa-2b subcutaneously once
weekly in weeks 1-6. Treatment repeats every 6 weeks for 2 courses in the absence of disease
progression or unacceptable toxicity. Patients with a partial response or stable disease
after completion of course 2 continue to receive gefitinib alone as above in the absence of
disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically for up to 2 years.
PROJECTED ACCRUAL: A total of 39 patients will be accrued for this study.
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Progression-free status at 6 months
at end of study
Primo N. Lara, MD
University of California, Davis
United States: Food and Drug Administration
|USC/Norris Comprehensive Cancer Center and Hospital||Los Angeles, California 90033-0804|
|University of California Davis Cancer Center||Sacramento, California 95817|
|City of Hope Comprehensive Cancer Center||Duarte, California 91010|