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
Phase 2
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Squamous Cell Cancer, Cancer of Head and Neck
Both
Squamous Cell Cancer, Cancer of Head and Neck
Trial Information
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
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
To compare the objective tumour response rate between cisplatin/5FU and cisplatin/5FU and ZD1839 combination in these patients
Principal Investigator
AstraZeneca Iressa Medical Sciences Director, MD
Investigator Role:
Study Director
Investigator Affiliation:
AstraZeneca
Authority:
United Kingdom: Department of Health
Study ID:
1839IL/0544
NCT ID:
NCT00255476
Start Date:
February 2004
Completion Date:
July 2007
Related Keywords:
- Squamous Cell Cancer
- Cancer of Head and Neck
- Carcinoma, Squamous Cell
- Neoplasms, Squamous Cell
- Head and Neck Neoplasms
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