ECOG 1302

Principal Investigator:	Bruce Culliney, MD
Time frame of study:	Ongoing
Location of Study:	Beth Israel Medical Center St.Luke's-Roosevelt Hospital Center
Contact:	Continuum Cancer Research Program (212) 844-6286

Summary:
The concurrent administration of docetaxel and ZD1839 (Iressa, gefitinib) have complementary therapeutic effects in the laboratory and may produce a survival advantage compared with the sequential use of single agent docetaxel followed by ZD1839 at the time of progression. Therefore, we propose a phase III randomized comparison of docetaxel administered weekly with or without ZD1839 in patients with recurrent/metastatic head and neck cancer.

Eligibility and Treatment Plan:
Patients, 18 years and older, with histologically or cytologically confirmed squamous cell carcinoma of the head and considered incurable by local therapies.

This study involves 2 treatment arms:

Arm A) Docetaxel + Placebo (inactive substance)
Arm B) Docetaxel + ZD1839

Benefits and/or Compensation:
Participants receive study-related medication at no charge under the supervision and care of a team of medical professionals. The information gathered from this study may be beneficial to future patients, and the combination of docetaxel and ZD1839 may improve overall survival time for metastatic/recurrent head and neck squamous cell cancer patients.