Safety Trial of IRESSA, Cisplatin and Radiation Therapy for Patients With Head and Neck Cancer
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.
Head and Neck Cancer
Drug: ZD1839 (IRESSA)
Procedure: Radiation Therapy
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|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|
- 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).
- To determine the time to disease progression, duration of response, and 2?year disease-free survival in subjects with unresectable tumors of the head and neck after combined therapy with ZD1839, cisplatin, and radiation.
- To determine the toxicities, and recovery from toxicities, of combined therapy with ZD1839, cisplatin, and radiation therapy.
- To determine dose-limiting toxicity as well as the recommended Phase II dose of ZD1839 given concurrently with cisplatin and radiation.
|Study Start Date:||April 2004|
|Study Completion Date:||September 2006|
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.
|United States, New York|
|Weill Medical College of Cornell University|
|New York, New York, United States, 10021|
|Principal Investigator:||Roger Keresztes, M.D.||Weill Medical College of Cornell University|