The IRESSA Novel Head and Neck Chemotherapy Evaluation Study

Phase 2

Completed

• Conditions: Squamous Cell Cancer; Cancer of Head and Neck

• Registration Number: NCT00255476
• Lead Sponsor: AstraZeneca

Brief Summary

The purpose of this study is to compare the objectie tumour response rate between the cisplatin/5FU and cisplatin/5FU plus ZD1839 combination

Detailed Description

Not available

Study Timeline

• Study Start: 2004-02
• Study First Submitted: 2005-11-17
• Study First Submitted QC: 2005-11-17
• Study First Posted: 2005-11-21
• Study Completion: 2007-07
• Status Verified: 2009-04
• Last Update Submitted: 2009-04-22
• Last Update Posted: 2009-04-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

Inclusion Criteria

• Provision of written informed consent
• Patients with histologically proven primary SCCHN
• Aged 18 or over

Exclusion Criteria

• Patients eligible for surgery with curative intent
• Other co-existing malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical cancer in situ
• Exclude UCNT

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
To compare the objective tumour response rate between cisplatin/5FU and cisplatin/5FU and ZD1839 combination in these patients

Secondary Outcome Measures

Name	Time	Method
To compare safety and tolerability in these patients

Trial Locations

Locations (1)

Research Site; 🇬🇧 London, United Kingdom