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NCT00255476 Clinical Trial

The IRESSA Novel Head and Neck Chemotherapy Evaluation Study

Cancer of Head and Neck Clinical Trial

Official title:
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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00255476
Other study ID # 1839IL/0544
Secondary ID
Status Completed
Phase Phase 2
First received November 17, 2005
Last updated April 22, 2009
Start date February 2004
Est. completion date July 2007

Study information
Verified date April 2009
Source AstraZeneca
Contact n/a
Is FDA regulated No
Health authority United Kingdom: Department of Health
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 64
Est. completion date July 2007
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• gefitinib

• cisplatin

• 5-flourouracil

Locations
Country Name City State
United Kingdom Research Site London

Sponsors (1)
Lead Sponsor Collaborator
AstraZeneca

Country where clinical trial is conducted

United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary To compare the objective tumour response rate between cisplatin/5FU and cisplatin/5FU and ZD1839 combination in these patients
Secondary To compare safety and tolerability in these patients
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