Study identifier:1839IL/0547
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Phase II study of Iressa with/without concurrent chemoradiotherapy in patients with advanced non-nasopharyngeal head and neck carcinoma and to study the effect of Iressa™ (ZD1839) on tumour gene expression profiles ®
head and neck cancer
Phase 2
No
Gefitinib
All
60
Interventional
18 Years +
Allocation: Non-randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Verified 01 Dec 2007 by AstraZeneca Pharmaceuticals
AstraZeneca Pharmaceuticals
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Two different patient populations will be targeted for this study. The first population (SP1) will include patients with recurrent/metastatic head and neck cancers, excluding salivary gland carcinomas. The second population (SP2) will include treatment-naïve patients with locally advanced squamous cell head and neck cancer (SCHNC). SP1 will be treated with palliative intent and the patients can be treatment-naïve or have received prior chemotherapy. Study treatment will consist of Iressa (gefitinib) alone. SP2 will be treated with radical intent. The patients must be treatment-naïve and study treatment will consist of induction Iressa for 3 weeks followed by a combination of Iressa plus cisplatin and concurrent irradiation.
Location
Location
Singapore, Singapore
Location
Hong Kong, Hong Kong
Arms | Assigned Interventions |
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