NCT01592383

Erlotinib Hydrochloride in Treating Patients With Malignant Peritoneal Mesothelioma

Phase II Study of Erlotinib for Patients With Malignant Peritoneal Mesothelioma (MPeM) Exhibiting EGFR Mutations

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: University of Chicago · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Malignant Peritoneal Mesothelioma

Interventions

Type	Name	Description
DRUG	erlotinib hydrochloride	Given PO

Timeline

• Start date: 2012-06-01
• Primary completion: 2017-02-01
• Completion: 2017-02-01
• First posted: 2012-05-07
• Last updated: 2018-10-16
• Results posted: 2018-10-16

Locations

1 site across 1 country: United States