Erlotinib Hydrochloride in Treating Patients With Malignant Peritoneal Mesothelioma
|Malignant Peritoneal Mesothelioma||Drug: erlotinib hydrochloride Other: laboratory biomarker analysis||Phase 2|
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||Phase II Study of Erlotinib for Patients With Malignant Peritoneal Mesothelioma (MPeM) Exhibiting EGFR Mutations|
- Objective response rate according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 [ Time Frame: Up to 1 year ]The exact 95% confidence interval of the response rate will be reported.
- PFS [ Time Frame: Time from study enrollment until disease progression or death up to 1 year ]
- OS [ Time Frame: Time from study enrollment until death up to 1 year ]
- Toxicity in terms of adverse events per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) criteria version 4.0 [ Time Frame: Until 30 days from the last dose of study drug ]
- Disease control rate - SD + PR + CR [ Time Frame: Up to 1 year ]
- Percentage of patients who have activating EGFR mutations among all screened patients [ Time Frame: Baseline ]
|Study Start Date:||June 2012|
|Study Completion Date:||February 2017|
|Primary Completion Date:||February 2017 (Final data collection date for primary outcome measure)|
Experimental: Treatment (enzyme inhibitor therapy)
Patients receive erlotinib hydrochloride PO QD. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Drug: erlotinib hydrochloride
Other Names:Other: laboratory biomarker analysis
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 erlotinib.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01592383
|United States, Illinois|
|University of Chicago Comprehensive Cancer Center|
|Chicago, Illinois, United States, 60637-1470|
|Principal Investigator:||Hedy Kindler||University of Chicago Comprehensive Cancer Center|