Kidney Cancer Clinical Trial
Official title:
A Phase II, Pharmacokinetic And Biologic Correlative Study of OSI-774, An EGFR Tyrosine Kinase Inhibitor, In Patients With Advanced Renal Cell Carcinoma
RATIONALE: Erlotinib may stop the growth of tumor cells by blocking the enzymes necessary
for tumor cell growth.
PURPOSE: Phase II trial to study the effectiveness of erlotinib in treating patients who
have advanced kidney cancer.
OBJECTIVES:
- Determine the antitumor activity of erlotinib in patients with advanced renal cell
carcinoma.
- Evaluate the safety and tolerability, in terms of the toxicity profile, of this drug in
these patients.
- Determine the biologic activity of this drug, in terms of early disease progression,
progression-free survival, 12-month survival rate, and overall survival, in these
patients.
- Determine the pharmacodynamics of this drug in these patients.
- Analyze the postreceptor effects of epidermal growth factor receptor-tyrosinase kinase
inhibition by this drug on cell cycle, apoptosis, and angiogenesis in tumor biopsies
from these patients.
- Correlate changes in biological measurements with indices of outcome in patients
treated with this drug.
OUTLINE: This is an open-label, multicenter study.
Patients receive oral erlotinib once daily on days 1-28. Courses repeat every 4 weeks for 52
weeks in the absence of disease progression or unacceptable toxicity.
Patients are followed every 2 months.
PROJECTED ACCRUAL: A total of 19-40 patients will be accrued for this study within 8-10
months.
;
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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