Status:
COMPLETED
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
Lead Sponsor:
AstraZeneca
Conditions:
Neoplasms, Squamous Cell
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 chemo...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2008
Estimated Enrollment :
224 Patients enrolled
Trial Details
Trial ID
NCT00229723
Start Date
November 1 2004
End Date
June 1 2008
Last Update
August 4 2009
Active Locations (25)
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1
Research Site
Aurora, Colorado, United States
2
Research Site
Dallas, Texas, United States
3
Research Site
Brussels, Belgium
4
Research Site
Ghent, Belgium