Kidney Cancer Clinical Trial
Official title:
Phase II Trial of ZD1839 (IRESSA®) and Pegylated Interferon Alfa 2b (PEG-Intron™) in Unresectable or Metastatic Renal Cell Carcinoma
RATIONALE: Gefitinib may stop the growth of kidney cancer by blocking blood flow to the
tumor and by blocking some of the enzymes needed for cell growth. PEG-interferon alfa-2b may
interfere with the growth of tumor cells and slow the growth of kidney cancer. Giving
gefitinib together with PEG-interferon alfa-2b may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving gefitinib together with
PEG-interferon alfa-2b works in treating patients with unresectable or metastatic kidney
cancer.
OBJECTIVES:
Primary
- Determine the 6-month progression-free survival of patients with unresectable or
metastatic renal cell carcinoma treated with gefitinib and PEG-interferon alfa-2b.
Secondary
- 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
treatment.
- 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
regimen.
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
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