IRESSA™ (Gefitinib) With Cisplatin Plus Radiotherapy for the Treatment of Previously Untreated Unresected Late Stage III/IV Non-Metastatic Head and Neck Squamous Cell Carcinoma
Neoplasms, Squamous Cell
About this trial
This is an interventional treatment trial for Neoplasms, Squamous Cell focused on measuring Head and Neck Squamous Cell Carcinoma, Head and Neck Squamous Cell Cancer, Squamous Cell Carcinoma, Squamous Cell Cancer
Eligibility Criteria
Inclusion Criteria: Histologically or cytologically confirmed stage III or IVA squamous cell carcinoma of the head and neck No prior surgery or chemotherapy/biological therapy/radiation therapy Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) Life expectancy of more than 12 weeks Exclusion Criteria: Cancers of the nasal space, oral cavity and larynx; or certain lung diseases. Abnormal blood chemistry; uncontrolled respiratory, cardiac, hepatic, or renal disease; or coexisting malignancies.
Sites / Locations
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Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Placebo Comparator
Experimental
Experimental
Experimental
Experimental
Placebo Comparator
Placebo Comparator
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Radiation + cisplatin; followed by placebo as maintenance therapy
250 mg gefitinib + radiation + cisplatin; followed by placebo as maintenance therapy
500 mg gefitinib + radiation + cisplatin; followed by placebo as maintenance therapy
gefitinib 250 mg + cisplatin + radiotherapy; followed by gefitinib 250 mg as maintenance therapy
gefitinib 500 mg + cisplatin + radiotherapy; followed by gefitinib 500 mg as maintenance therapy
placebo + cisplatin + radiotherapy; followed by gefitinib 250 mg as maintenance therapy
placebo + cisplatin + radiotherapy; followed by gefitinib 500 mg as maintenance therapy