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

• Status: Completed
• Trial end date: 2008-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The primary purpose of this study is to assess the effectiveness of ZD1839 250 mg and 500 mg when given either concomitantly or as maintenance to a standard therapy of radiotherapy (X-rays) plus chemotherapy (cisplatin) in terms of local disease control (progression-free) rate at 2 years.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AstraZeneca
• Treatments: Cisplatin; Gefitinib

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.