Tongue Cancer Clinical Trial
Official title:
A Biomarker Driven Pilot Study of the Pan-class I PI3K Inhibitor NVP-BKM120 in Combination With Cetuximab in Patients With Recurrent/Metastatic Head and Neck Cancer
This pilot randomized phase I/II trial studies the side effects and best dose of PI3K inhibitor BKM120 when given together with cetuximab and to see how well it works in treating patients with recurrent or metastatic head and neck cancer. PI3K inhibitor BKM120 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumors to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving PI3K inhibitor BKM120 together with cetuximab may kill more tumor cells
PRIMARY OBJECTIVES: I. Induction of compensatory signaling/feedback loop signaling after one week of BKM120 (PI3K inhibitor BKM120) (run-in) compared to patients not treated with BKM120. II. Safety and tolerability of combined treatment with BKM120 and cetuximab. SECONDARY OBJECTIVES: I. Induction of apoptosis after one week of BKM120 (run-in) compared to patients not treated with BKM. II. Tumor shrinkage (based Response Evaluation Criteria in Solid Tumors [RECIST] version 1.1 [V1.1] measurements) in patients treated with combination. III. Response rate (based RECIST V1.1 measurements) in patients treated with combination. IV. Overall survival. V. Progression free survival. OUTLINE: This is a phase I, dose-escalation study of PI3K inhibitor BKM120, followed by a phase II study. RUN-IN-PERIOD: Patients are randomized to 1 of 2 treatment arms. ARM I: Patients receive PI3K inhibitor BKM120 orally (PO) once daily (QD) on days -7 to 0. Patients complete 1 week washout before dose escalation. ARM II: Patients receive no treatment on days -7 to 0. All patients receive PI3K inhibitor BKM120 PO QD on days 1-28 and cetuximab intravenously (IV) over 60-120 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up for 28 days. ;
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