Conditions: Kidney Cancer
Keywords: recurrent renal cell cancer stage III renal cell cancer stage IV renal cell cancer
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 41
Healthy volunteers: no

Brief summary:
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.

Detailed description:
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.

Arms:
arm 1: None

Interventions: intervention 1: OSI-774
Intervention descriptions: intervention 1: OSI-774 is an orally active, potent, selective inhibitor of the epidermal growth factor receptor (EGFR) tyrosine kinase.

Protocol document: