NCT00185835

Cisplatin and ZD1839 + Re-Irradiation in Recurrent Squamous Cell Cancer of the Head and Neck

Phase I Study of Cisplatin And ZD1839 (IRESSA®) in Combination With Concomitant Re-Irradiation in Patients With Loco-Regional Recurrent Squamous Cell Cancer of the Head and Neck

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Stanford University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To determine safety profile of the epidermal growth factor receptor (EGFR) antagonist, ZD1839 in combination with cisplatin and radiation therapy in patients with local-regional recurrent squamous cell cancer of the head and neck. To study the effects of ZD1839 combined with either cisplatin or radiotherapy on signal transduction pathway gene expression in tumor cells in patients with local-regional recurrent squamous cell cancer of the head and neck using micro array analysis from tumor samples taken at the time of relapse and during treatment.

Conditions

• Head and Neck Cancer
• Carcinoma, Squamous Cell

Interventions

Type	Name	Description
DRUG	ZD-1839
DRUG	Cisplatin

Timeline

• Start date: 2002-06-01
• Primary completion: 2006-07-01
• First posted: 2005-09-16
• Last updated: 2010-03-29

Locations

1 site across 1 country: United States