Spots Global Cancer Trial Database for Safety Trial of IRESSA, Cisplatin and Radiation Therapy for Patients With Head and Neck Cancer

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Trial Identification

Brief Title: Safety Trial of IRESSA, Cisplatin and Radiation Therapy for Patients With Head and Neck Cancer

Official Title: 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

Study ID: NCT00195078

Conditions

Head and Neck Cancer

Interventions

ZD1839 (IRESSA)

Cisplatin

Radiation Therapy

Study Description

Brief Summary: The purpose of this study is to find out whether adding ZD1839 to standard treatment (Cisplatin and Radiation Therapy) of unresectable head and neck cancers is better than cisplatin and radiation alone.

Detailed Description: 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.