Erlotinib in Treating Patients With Advanced Kidney Cancer (OSI-774)
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|ClinicalTrials.gov Identifier: NCT00045487|
Recruitment Status : Completed
First Posted : January 27, 2003
Results First Posted : January 27, 2014
Last Update Posted : January 27, 2014
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.
|Condition or disease||Intervention/treatment||Phase|
|Kidney Cancer||Drug: OSI-774||Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||41 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||June 2002|
|Primary Completion Date :||May 2008|
|Study Completion Date :||May 2008|
OSI-774 is an orally active, potent, selective inhibitor of the epidermal growth factor receptor (EGFR) tyrosine kinase.
- 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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|