drugset

drugset / Trial / NCT00400374

Secondary Primary Tumor Prevention With EGFR, OSI-774, and Cyclooxygenase-2

NCT00400374 ↗

Phase 1 Completed 10 enrolled Emory University Genentech, Inc. · collab National Cancer Institute (NCI) · collab

NaSingle-groupOpen-labelPrevention

Summary

This is a phase I study of second primary tumor prevention in early stage (stage I/II) patients diagnosed with squamous cell carcinoma of the head and neck (SCCHN).

Timeline

Start: 2007-08
Primary completion: 2012-12
Completion: 2016-11

Publications

Kim P, Saba NF, McCook-Veal A, Liu Y, Klein AM, Beitler JJ, Chen A, Khuri FR, Shin DM. Prospective Pilot Study of Second Primary Tumor Prevention With Erlotinib and Celecoxib in Early-Stage Squamous Cell Carcinoma of the Head and Neck: Long-Term Follow-Up. Head Neck. 2025 Sep;47(9):2594-2602. doi: 10.1002/hed.28178. Epub 2025 Apr 28.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Celecoxib	Other / unclassified	400 mg	—
Subject	Erlotinib	Small molecule	50 mg	—
Subject	Erlotinib	Small molecule	75 mg	—
Subject	Erlotinib	Small molecule	100 mg	—

Indications