Back to resultsThe IRESSA Novel Head and Neck Chemotherapy Evaluation Study
Primary Purpose
Squamous Cell Cancer, Cancer of Head and Neck
Status
Completed
Phase
Phase 2
Locations
United Kingdom
Study Type
Interventional
Intervention
gefitinib
cisplatin
5-flourouracil
Sponsored by
About this trial
This is an interventional treatment trial for Squamous Cell Cancer
Eligibility Criteria
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
Sites / Locations
- Research Site
Outcomes
Primary Outcome Measures
To compare the objective tumour response rate between cisplatin/5FU and cisplatin/5FU and ZD1839 combination in these patients
Secondary Outcome Measures
To compare safety and tolerability in these patients
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00255476
Brief Title
The IRESSA Novel Head and Neck Chemotherapy Evaluation Study
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2009
Overall Recruitment Status
Completed
Study Start Date
February 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
AstraZeneca
4. Oversight
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Squamous Cell Cancer, Cancer of Head and Neck
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
64 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
gefitinib
Intervention Type
Drug
Intervention Name(s)
cisplatin
Intervention Type
Drug
Intervention Name(s)
5-flourouracil
Primary Outcome Measure Information:
Title
To compare the objective tumour response rate between cisplatin/5FU and cisplatin/5FU and ZD1839 combination in these patients
Secondary Outcome Measure Information:
Title
To compare safety and tolerability in these patients
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
AstraZeneca Iressa Medical Sciences Director, MD
Organizational Affiliation
AstraZeneca
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
London
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
The IRESSA Novel Head and Neck Chemotherapy Evaluation Study
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