Phase II Study of Erlotinib for Patients With Malignant Peritoneal Mesothelioma (MPeM) Exhibiting EGFR Mutations
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.
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
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.
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.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Objective response rate according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
The exact 95% confidence interval of the response rate will be reported.
Up to 1 year
University of Chicago Comprehensive Cancer Center
United States: Institutional Review Board
|University of Chicago Comprehensive Cancer Center||Chicago, Illinois 60637-1470|