The purpose of this study is to test the drug erlotinib (erlotinib hydrochloride) in people with malignant peritoneal mesothelioma who have a specific genetic mutation in their cancer. Erlotinib has been approved by the United States Food and Drug Administration (FDA) for other cancers, but erlotinib has not been approved for malignant peritoneal mesothelioma. This research is being done because there is no current standard treatment for malignant peritoneal mesothelioma and the study doctors want to see how erlotinib affects malignant peritoneal mesothelioma.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Given PO
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, United States
Objective Response Rate
Objective Response Rate is calculated according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
Time frame: 1 year
PFS
Progression free survival (PFS) defined as time from study enrollment until disease progression or death.
Time frame: 1 year
OS
Overall survival measured as the time from study enrollment until death.
Time frame: 1 year
Toxicity
Toxicity is calculated in terms of adverse events per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) criteria version 4.0
Time frame: 30 days from the last dose of study drug
Disease Control Rate - SD + PR + CR
Disease Control Rate - SD + PR + CR is calculated as the percentage of patients with either complete response (CR: disappearance of all target lesions), or with partial response (PR: at least 30% decrease in the sum of longest diameter of target lesions, taking as reference the baseline sum longest diameter of target lesions), or stable disease (SD: neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease of an increase of at least 20% in the sum of the longest diameter of the target lesions taking as reference the smallest sum of longest diameter recorded since the treatment started or the appearance of one or more new lesions).
Time frame: 1 year
EGFR Mutations Percentage
EGFR Mutations Percentage is calculated as the percentage of patients who have activating EGFR mutations among all screened patients.
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Purpose
TREATMENT
Masking
NONE
Enrollment
2
Time frame: Baseline