Effect of Iressa With/Without Concurrent Chemoradiotherapy on Tumor Gene Expression Profiles in Patients With Advanced Non-Nasopharyngeal Head and Neck Carcinoma

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00228488
• Date of registration: 27/09/2005
• Primary sponsor: AstraZeneca
• Public title: Effect of Iressa With/Without Concurrent Chemoradiotherapy on Tumor Gene Expression Profiles in Patients With Advanced Non-Nasopharyngeal Head and Neck Carcinoma
• Scientific 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 ®
• Date of first enrolment: June 2004
• Target sample size: 60
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00228488
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

Hong Kong, Singapore

Contacts

• Name: AstraZeneca Medical Department
• Affiliation: AstraZeneca

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Head and Neck Cancer

Intervention(s)

Drug: Gefitinib

Primary Outcome(s)

To study the effect of Iressa on gene expression profiles in patients with head and neck cancer

Secondary Outcome(s)

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

Secondary ID(s)

1839IL/0547

Source(s) of Monetary Support

Please refer to primary and secondary sponsors