Trial Information
A Phase I/II Trial of ZD1839 (Iressa) Given Concurrently With Cisplatin and Radiotherapy in Patients With Locally Advanced Head and Neck Cancer
Inclusion Criteria:
- Histologically confirmed head and neck cancer
- Lymph node negative or positive
- Metastasis negative
- Chemo- and radiotherapy naïve
- WHO 0-2
- Measurable disease by RECIST
- Written informed consent
Exclusion Criteria:
- Severe alcohol abuse
- Active ILD
- Co-existing chronic gastrointestinal disease(s)
- Brain metastasis
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Parts 1 and 2: Safety (Incidence of DLTs)
Principal Investigator
AstraZeneca Finland Medical Director, MD
Investigator Role:
Study Director
Investigator Affiliation:
AstraZeneca
Authority:
Finland: Finnish Medicines Agency
Study ID:
1839IL/0151
NCT ID:
NCT00239304
Start Date:
June 2003
Completion Date:
March 2006
Related Keywords:
- Head and Neck Neoplasms
- Stage III Head and Neck Cancer
- Stage IV Head and Neck Cancer
- Neoplasms
- Head and Neck Neoplasms