Head and Neck Cancer
Conditions
Keywords
advanced non-nasopharyngeal head and neck carcinoma
Brief summary
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.
Interventions
DRUGGefitinib
Sponsors
AstraZeneca
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Histologically confirmed carcinoma of the head and neck (excluding salivary gland and nasopharyngeal carcinoma), namely squamous cell or undifferentiated carcinoma * Recurrent/metastatic disease that is not amenable to cure * Accessible tumour site for repeat tumour samplings * Patients must be agreeable to repeated tumour samplings. * Measurable disease sites by computed tomography (CT) imaging is preferred but not mandatory. * Adequate performance status of ECOG 0 - 2 * Life expectancy of at least 3 months * Written informed consent to participate in the study
Exclusion criteria
* Prior treatment with tyrosine kinase inhibitor or anti-epidermal growth factor receptor (EGFR) therapy * Refusal for repeated tumour samplings * Tumour site deemed unsafe for repeated samplings due to risk of bleeding * In the opinion of the investigator, any evidence of severe or uncontrolled systemic disease (eg. unstable or uncompensated respiratory disorder, cardiac failure, hepatic decompensation, renal failure, uncontrolled metabolic disorders such as diabetes mellitus, or uncontrolled significant infections) * Any bleeding disorders * Pregnancy or breast-feeding (women of child-bearing potential) * Other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical carcinoma-in-situ Inclusion Criteria for SP2: * Histologically confirmed carcinoma of the head and neck (excluding salivary gland and nasopharyngeal carcinoma), namely squamous cell carcinoma or undifferentiated carcinoma * Locally advanced disease (stage III/IV) without distant metastases, not amenable to curative resection, or patient refusal for surgery * Accessible primary site for repeat tumour samplings * Patients agreeable to repeated tumour samplings * Evaluable and/or measurable disease sites on CT scans * Adequate performance status of ECOG 0 - 1 * Written informed consent to participate in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To study the effect of Iressa on gene expression profiles in patients with head and neck cancer | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Hong Kong, Singapore
Outcome results
None listed