Squamous Cell Carcinoma of the Head and Neck
Conditions
Keywords
Squamous cell carcinoma of the head and neck
Brief summary
This study is to compare ZD1839 (250mg and 500mg) versus methotrexate in head and neck cancer in terms of overall survival.
Interventions
DRUGGefitinib
DRUGmethotrexate
Sponsors
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Histological confirmation of evidence of squamous cell carcinoma of the head and neck. * Tumors have progressed after primary treatment with radiation or chemoradiation and have failed to respond to at least one course of standard platinum-based chemotherapy. * Tumors have progressed after primary treatment with radiation or chemoradiation and are considered unsuitable for platinum-based chemotherapy.
Exclusion criteria
* Carcinomas of the post-nasal space, thyroid, sinus or salivary gland tumors. * Isolated recurrent disease that may be amenable to local therapy; e.g., surgical intervention or radiation therapy. * Known severe hypersensitivity to ZD1839, Methotrexate or any of the excipients of these products.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Compare ZD1839 versus methotrexate in overall survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Compare ZD1839 versus methotrexate in symptom improvement, tumor response, safety and tolerability and quality of life - assessed throughout the study. | — |
Countries
Argentina, Australia, Belgium, Brazil, Canada, Croatia, Czechia, Estonia, Greece, India, Israel, Italy, Latvia, Lithuania, Malaysia, Netherlands, Norway, Russia, Slovenia, South Africa, Spain, Sweden, Thailand, United Kingdom, United States
Outcome results
None listed