Malignant Peritoneal Mesothelioma Clinical Trial
Official title:
Phase II Study of Erlotinib for Patients With Malignant Peritoneal Mesothelioma (MPeM) Exhibiting EGFR Mutations
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.
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.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT06057935 -
A Study of Additional Chemotherapy After Surgery for People With Malignant Peritoneal Mesothelioma
|
Phase 2 | |
| Completed |
NCT02151448 -
αDC1 Vaccine + Chemokine Modulatory Regimen (CKM) as Adjuvant Treatment of Peritoneal Surface Malignancies
|
Phase 1/Phase 2 |