Phase I/II Study of Postoperative Adjuvant Chemoradiation for Advanced-Stage Cutaneous Squamous Cell Carcinoma of the Head and Neck (cSCCHN)

Summary

This phase I/II trial studies the side effects and best dose of linsitinib when given together with erlotinib hydrochloride and radiation therapy after surgery in treating patients with advanced or recurrent head and neck cancer. Erlotinib hydrochloride and linsitinib 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 radiation therapy together with erlotinib hydrochloride and linsitinib may kill more tumor cells. Giving these treatments after surgery may kill any tumor cells that remain after surgery.

Timeline

Start

2011-12

Primary completion

2013-09

Completion

2013-09

Outcome

Outcome not reported

Stopped: “Drug manufacturer, Astellas Pharma, informed us that safety and efficacy of Erlotinib and OSI-906 in other oncology studies was determined to be unfavorable.”

Drugs

Indications