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

Completed · Phase 2

Conditions studied: Neoplasms, Squamous Cell

In brief

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.

Key facts

Study ID

NCT00229723

Run by

AstraZeneca

People needed

224

Starts

2004-11-01

Expected to finish

2008-06-01

Last updated by the study team

2009-08-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Research Site — Aurora, Colorado, United States
• Research Site — Dallas, Texas, United States
• Research Site — Brussels, Belgium
• Research Site — Ghent, Belgium
• Research Site — Leuven, Belgium
• Research Site — Hradec Králové, Czechia
• Research Site — Pardubice, Czechia
• Research Site — Pilsen, Czechia
• Research Site — Berlin, Germany
• Research Site — Essen, Germany
• Research Site — Münster, Germany
• Research Site — Saarbrücken, Germany
• Research Site — Bangalore, India
• Research Site — Mumbai, India
• Research Site — New Delhi, India
• Research Site — Thiruvananthapuram, India
• Research Site — Gliwice, Poland
• Research Site — Krakow, Poland
• Research Site — Lodz, Poland
• Research Site — Lublin, Poland
• Research Site — Warsaw, Poland
• Research Site — Belgrade, Serbia
• Research Site — Kamenitz, Serbia
• Research Site — Taipei, Taiwan
• Research Site — Taoynan, Taiwan

Full record on ClinicalTrials.gov

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