NCT01332279

Everolimus, Erlotinib Hydrochloride, and Radiation Therapy in Treating Patients With Recurrent Head and Neck Cancer Previously Treated With Radiation Therapy

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

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Fox Chase Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Recurrent Metastatic Squamous Neck Cancer With Occult Primary
• Recurrent Salivary Gland Cancer
• Recurrent Squamous Cell Carcinoma of the Hypopharynx
• Recurrent Squamous Cell Carcinoma of the Larynx
• Recurrent Squamous Cell Carcinoma of the Lip and Oral Cavity
• Recurrent Squamous Cell Carcinoma of the Oropharynx
• Recurrent Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity
• Recurrent Verrucous Carcinoma of the Larynx
• Recurrent Verrucous Carcinoma of the Oral Cavity
• Salivary Gland Squamous Cell Carcinoma
• Tongue Cancer

Interventions

Type	Name	Description
DRUG	everolimus	Given PO
DRUG	erlotinib hydrochloride	Given PO
PROCEDURE	biopsy	Correlative studies
OTHER	laboratory biomarker analysis	Correlative studies
OTHER	immunohistochemistry staining method	Correlative studies
GENETIC	polyacrylamide gel electrophoresis	Correlative studies
OTHER	pharmacological study	Correlative studies
RADIATION	external beam radiation therapy	Undergo EBRT
GENETIC	microarray analysis	Correlative studies

Timeline

• Start date: 2011-04-01
• Primary completion: 2011-05-01
• Completion: 2011-05-01
• First posted: 2011-04-11
• Last updated: 2023-04-04

Locations

1 site across 1 country: United States