Trial Information
A 2 Part Phase 2 Trial to Evaluate ZD1839 (Iressa™) & Radiotherapy in Patients w/Locally Advanced Inoperable Squamous Cell Carcinoma of the Head & Neck
Inclusion Criteria:
- Histologically Confirmed locally advanced Squamous Cell Carcinoma of Head and neck
- At least one measurable tumour lesion
Exclusion Criteria:
- No previous treatment such as chemotherapy, radiotherapy and/or surgery for Carcinoma
Head and Neck
- No other co-existing malignancies or malignancies diagnosed within the last 5 years
with the exception of basal cell carcinoma or cervical cancer in situ
- Any evidence of severe or uncontrolled systemic disease (e.g. unstable or
uncompensated respiratory, cardiac, hepatic or renal disease)
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Tumour Response Rate, as complete response (CR) and partial response (PR) . Six months after Last Patient In.
Principal Investigator
AstraZeneca Italy Medical Director, MD
Investigator Role:
Study Director
Investigator Affiliation:
AstraZeneca
Authority:
Italy: The Italian Medicines Agency
Study ID:
1839IL/0070
NCT ID:
NCT00233636
Start Date:
July 2003
Completion Date:
Related Keywords:
- Head and Neck Cancer
- Carcinoma, Squamous Cell
- Squamous Cell Carcinoma of Head and Neck
- Inoperable locally advanced Squamous Cell Carcinoma of Head and Neck
- Carcinoma
- Carcinoma, Squamous Cell
- Head and Neck Neoplasms