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
Verified date | April 2009 |
Source | AstraZeneca |
Contact | n/a |
Is FDA regulated | No |
Health authority | United Kingdom: Department of Health |
Study type | Interventional |
The purpose of this study is to compare the objectie tumour response rate between the cisplatin/5FU and cisplatin/5FU plus ZD1839 combination
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United Kingdom | Research Site | London |
Lead Sponsor | Collaborator |
---|---|
AstraZeneca |
United Kingdom,
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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