The IRESSA Novel Head and Neck Chemotherapy Evaluation Study

A Randomised Phase II Study to Investigate the Feasibility and Benefits of Combining ZD1839 and Cisplatin/5FU, as Induction Therapy, in Patients With Locally and Advanced Squamous Cell Carcinoma of the Head and Neck

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00255476

Enrollment

Registered

2005-11-21

Start date

2004-02-29

Completion date

2007-07-31

Last updated

2009-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Squamous Cell Cancer, Cancer of Head and Neck

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

Interventions

DRUGgefitinib

DRUGcisplatin

DRUG5-flourouracil

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
To compare the objective tumour response rate between cisplatin/5FU and cisplatin/5FU and ZD1839 combination in these patients	—

Secondary

Measure	Time frame
To compare safety and tolerability in these patients	—

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026