Phase I-II Study of ZD1839 (IRESSA®), Cisplatin, and External-Beam Radiation Therapy in Patients With Locally Advanced, Non-Metastatic, Squamous Cell Carcinoma of the Head and Neck
This is a Phase I-II, open-label, dose-escalation study in subjects with advanced head or
neck cancer. Subjects will receive daily ZD1839 during a course of standard radiation
therapy accompanied by cisplatin.
Subjects are adults with Stage III-IV squamous cell carcinoma of the oral cavity,
oropharynx, larynx, or hypopharynx, who are in medically stable condition, with an Eastern
Cooperative Oncology Group (ECOG) Performance Status of £ 1, stable hepatic and bone marrow
function, and a life expectancy of at least 6 months. Subjects should have no previous
cancer history (with the exception of squamous cell carcinoma of the skin or cervical cancer
in situ) and no prior treatment with radiation, chemotherapy, or definitive surgical
therapy. Subjects in the Phase II portion of the trial must have measurable disease as
defined by RECIST criteria.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To explore whether the addition of ZD1839 to standard treatment of unresectable head and neck cancers (i.e., cisplatin and radiation therapy) improves the clinical complete response rate (as measured by RECIST criteria).
Roger Keresztes, M.D.
Weill Medical College of Cornell University
United States: Food and Drug Administration
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