Finding studies
Finding studies
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Lead
University of Chicago
With
PRIMARY OBJECTIVES: I. To determine the objective response rate (complete response \[CR\] + partial response \[PR\]) of erlotinib in malignant peritoneal mesothelioma (MPeM) patients who have epidermal growth factor receptor (EGFR) mutations. SECONDARY OBJECTIVES: I. To determine the percentage of patients with MPeM who have EGFR mutations. II. To characterize asbestos exposure history and other clinical parameters of patients with MPeM who do or do not have EGFR mutations. III. To determine the disease control rate (CR + PR + stable disease \[SD\]) of MPeM patients who have EGFR mutations and are treated with erlotinib. IV. To determine the progression-free survival (PFS) of MPeM patients who have EGFR mutations and are treated with erlotinib. V. To determine the median overall survival (OS) of MPeM patients who have EGFR mutations and are treated with erlotinib. VI. To evaluate toxicity in MPeM patients who have EGFR mutations and are treated with erlotinib. TERTIARY OBJECTIVES: I. To characterize the specific EGFR mutations observed in MPeM patients. II. To correlate tumor markers (cancer antigen \[CA\] 125 and soluble mesothelin-related peptide \[SMRP\]) with response rate, PFS, and OS in MPeM patients treated with erlotinib. III. To correlate immunohistochemical staining of EGFR, phosphorylated (p)-EGFR, MET (Metastasis), E-cadherin, vimentin, and CBL (Casitas B-lineage Lymphoma)with EGFR mutational status and, if present, particular EGFR mutation noted. IV. To correlate immunohistochemical staining of EGFR, p-EGFR, MET, E-cadherin, vimentin, and CBL with response rate, PFS, and OS in MPeM patients treated with erlotinib. OUTLINE: Patients receive erlotinib hydrochloride orally (PO) once daily (QD). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up periodically.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
