Erlotinib in Treating Patients With Advanced Kidney Cancer (OSI-774)
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.
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|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|
- Number of Patients With Ani-tumor Activity After Taking OSI-774. [ Time Frame: Disease progression or 52 weeks duration ]Antitumor activity is measured with conventional techniques such as CT, MRI or X-ray. Scans are done at baseline then evaluated for response every 2 months. All tumor measurements must be recorded millimeters (or decimal fractions of centimeters).
|Study Start Date:||June 2002|
|Study Completion Date:||May 2008|
|Primary Completion Date:||May 2008 (Final data collection date for primary outcome measure)|
OSI-774 is an orally active, potent, selective inhibitor of the epidermal growth factor receptor (EGFR) tyrosine kinase.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00045487
|United States, Texas|
|University of Texas Health Science Center San Antonio|
|San Antonio, Texas, United States, 78229|
|Study Chair:||Anthony W. Tolcher, MD||University of Texas Health Science Center San Antonio|
|Principal Investigator:||Alain Mita, MD||Cedar Sinai|