NCT00045487

Erlotinib in Treating Patients With Advanced Kidney Cancer

A Phase II, Pharmacokinetic And Biologic Correlative Study of OSI-774, An EGFR Tyrosine Kinase Inhibitor, In Patients With Advanced Renal Cell Carcinoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 41 (actual)
• Sponsor: The University of Texas Health Science Center at San Antonio · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Kidney Cancer

Interventions

Type	Name	Description
DRUG	OSI-774	OSI-774 is an orally active, potent, selective inhibitor of the epidermal growth factor receptor (EGFR) tyrosine kinase.

Timeline

• Start date: 2002-06-01
• Primary completion: 2008-05-01
• Completion: 2008-05-01
• First posted: 2003-01-27
• Last updated: 2014-01-27
• Results posted: 2014-01-27

Locations

1 site across 1 country: United States