Erlotinib Hydrochloride in Treating Patients With Malignant Peritoneal Mesothelioma
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.
Malignant Peritoneal Mesothelioma
Drug: erlotinib hydrochloride
Other: laboratory biomarker analysis
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]
- OS [ Time Frame: Time from study enrollment until death up to 1 year ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: Yes ]
- Disease control rate - SD + PR + CR [ Time Frame: Up to 1 year ] [ Designated as safety issue: No ]
- Percentage of patients who have activating EGFR mutations among all screened patients [ Time Frame: Baseline ] [ Designated as safety issue: No ]
|Study Start Date:||June 2012|
|Estimated Study Completion Date:||June 2016|
|Estimated Primary Completion Date:||June 2015 (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||Recruiting|
|Chicago, Illinois, United States, 60637-1470|
|Contact: Hedy L. Kindler, MD 773-702-0360 email@example.com|
|Contact: Jennifer Shouldis, RN 773-834-3137 firstname.lastname@example.org|
|Principal Investigator: Hedy L. Kindler|
|Principal Investigator:||Hedy Kindler||University of Chicago Comprehensive Cancer Center|