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

AstraZeneca

Status and phase

Completed

Phase 2

Conditions

Head and Neck Cancer

Treatments

Drug: Gefitinib

Study type

Interventional

Funder types

Industry

Identifiers

NCT00228488

1839IL/0547

Details and patient eligibility

About

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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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