Effect of Iressa With/Without Concurrent Chemoradiotherapy on Tumor Gene Expression Profiles in Patients With Advanced Non-Nasopharyngeal Head and Neck Carcinoma
|ClinicalTrials.gov Identifier: NCT00228488|
Recruitment Status : Completed
First Posted : September 29, 2005
Last Update Posted : December 19, 2007
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.
|Condition or disease||Intervention/treatment||Phase|
|Head and Neck Cancer||Drug: Gefitinib||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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 ®|
|Study Start Date :||June 2004|
|Study Completion Date :||December 2005|
- To study the effect of Iressa on gene expression profiles in patients with head and neck cancer
- To study the efficacy of Iressa as monotherapy as first line or after failing prior platinum-based regimen in patients with recurrent/metastatic head and neck carcinomas
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00228488
|Hong Kong, Hong Kong|
|Study Director:||AstraZeneca Medical Department||AstraZeneca|