Erlotinib Hydrochloride in Treating Patients With Malignant Peritoneal Mesothelioma
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|ClinicalTrials.gov Identifier: NCT01592383|
Recruitment Status : Completed
First Posted : May 7, 2012
Results First Posted : October 16, 2018
Last Update Posted : October 16, 2018
|Condition or disease||Intervention/treatment||Phase|
|Malignant Peritoneal Mesothelioma||Drug: erlotinib hydrochloride||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||2 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study of Erlotinib for Patients With Malignant Peritoneal Mesothelioma (MPeM) Exhibiting EGFR Mutations|
|Study Start Date :||June 2012|
|Actual Primary Completion Date :||February 2017|
|Actual Study Completion Date :||February 2017|
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
- Objective Response Rate [ Time Frame: 1 year ]Objective Response Rate is calculated according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
- PFS [ Time Frame: 1 year ]Progression free survival (PFS) defined as time from study enrollment until disease progression or death.
- OS [ Time Frame: 1 year ]Overall survival measured as the time from study enrollment until death.
- Toxicity [ Time Frame: 30 days from the last dose of study drug ]Toxicity is calculated in terms of adverse events per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) criteria version 4.0
- Disease Control Rate - SD + PR + CR [ Time Frame: 1 year ]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).
- EGFR Mutations Percentage [ Time Frame: Baseline ]EGFR Mutations Percentage is calculated as the percentage of patients who have activating EGFR mutations among all screened patients.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|