Status:
COMPLETED
Effect of Iressa With/Without Concurrent Chemoradiotherapy on Tumor Gene Expression Profiles in Patients With Advanced Non-Nasopharyngeal Head and Neck Carcinoma
Lead Sponsor:
AstraZeneca
Conditions:
Head and Neck Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2004
Trial Type :
INTERVENTIONAL
End Date :
December 1 2005
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00228488
Start Date
June 1 2004
End Date
December 1 2005
Last Update
December 19 2007
Active Locations (2)
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1
Hong Kong, Hong Kong
2
Singapore, Singapore