Head and Neck Cancer Clinical Trial
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 Iressaâ„¢ (ZD1839) on Tumour Gene Expression Profiles ®
Verified date | December 2007 |
Source | AstraZeneca |
Contact | n/a |
Is FDA regulated | No |
Health authority | Singapore: Domain Specific Review Boards |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 60 |
Est. completion date | December 2005 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 Exclusion Criteria for SP2: - Presence of distant metastases - Prior treatment with EGFR-targeted therapy, or chemotherapy or radiotherapy to head and neck region - Refusal for repeated tumour samplings - Tumour site deemed unsafe for repeated samplings due to risk of bleeding - Common toxicity criteria (CTC) grade 2 or greater pre-existing motor or sensory neuropathy - 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 - Absolute neutrophil count of less than 1000/mm3, and platelet count of less than 100,000/mm3 - Serum bilirubin greater than 2 times the upper limit of normal range (ULNR) - Serum alanine aminotransferase (ALT) and serum aspartate amino transferase (AST) greater than 2.5 times ULNR - Serum creatinine greater than 143 umol/litre - 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 |
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
AstraZeneca |
Hong Kong, Singapore,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To study the effect of Iressa on gene expression profiles in patients with head and neck cancer | |||
Secondary | 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 |
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