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

NCT00228488 | Completed Phase 2

• 1 other identifier: 1839IL/0547
• Study Type: interventional
• Target: 60
• Locations: 2 countries
• Sites: 2

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.

Conditions

Head and Neck Cancer

Keywords

advanced non-nasopharyngeal head and neck carcinoma

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (1)

• 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

Interventions

Gefitinib DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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
• Presence of distant metastases

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (2)

Unknown Facility

Hong Kong, Hong Kong

Location

Unknown Facility

Singapore, Singapore

Location

MeSH Terms

Conditions

Head and Neck Neoplasms

Interventions

Gefitinib

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Intervention Hierarchy (Ancestors)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• AstraZeneca Medical Department

  AstraZeneca

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 27, 2005
• First Posted: September 29, 2005
• Study Start: June 1, 2004
• Study Completion: December 1, 2005
• Last Updated: December 19, 2007

Record last verified: 2007-12

Locations

SG (1); HK (1)