Tongue Cancer Clinical Trial
Official title:
A Phase I Dose Escalation Study of the mTOR Inhibitor Everolimus (RAD001) and Erlotinib Concurrently With Radiation Therapy in the Re-Irradiation Setting for Head and Neck Cancer
This phase I trial studies the side effects and best dose of giving everolimus (RAD001) and erlotinib hydrochloride together with radiation therapy in treating patients with recurrent head and neck cancer previously treated with radiation therapy. RAD001 and erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Radiation therapy uses high energy x rays to kill tumor cells. Giving RAD001 and erlotinib hydrochloride together with radiation therapy may kill more tumor cells.
PRIMARY OBJECTIVES: I. To establish the maximum tolerated dose (MTD) and safety of RAD001 given concurrently with external beam radiation therapy (EBRT) in the re-irradiation setting for head and neck cancer. SECONDARY OBJECTIVES: I. Obtain preliminary data on response rate. II. Determine progression-free survival at 6 and 12 months and overall survival. III. Perform correlative studies to evaluate and characterize biological features of recurrent or second primary tumors, as well as to follow surrogates of mammalian target of rapamycin (mTOR), epidermal growth factor receptor (EGFR) and hypoxia-inducible factor 1-alpha (HIF-1α) inhibition. OUTLINE: This is a dose-escalation study of everolimus and erlotinib hydrochloride. Patients receive RAD001 orally (PO) and erlotinib hydrochloride PO once daily (QD). Treatment continues for up to 2 years in the absence of disease progression or unacceptable toxicity. Patients also undergo EBRT twice daily (BID) 5 days a week for 5 weeks. After completion of study treatment, patients are followed up for 2 years. ;
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