Effect of Iressa With/Without Concurrent Chemoradiotherapy on Tumor Gene Expression Profiles in Patients With Advanced Non-Nasopharyngeal Head and Neck Carcinoma
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|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)|
|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|
|Actual 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00228488
|Hong Kong, Hong Kong|
|Study Director:||AstraZeneca Medical Department||AstraZeneca|