Gefitinib (Iressa) in Combo With Chemoradiation in Patients With Locally Advanced Head & Neck Cancer
Phase 1
Completed
- Conditions
- Head and Neck Neoplasms
- Registration Number
- NCT00239304
- Lead Sponsor
- AstraZeneca
- Brief Summary
To determine the safety and tolerability of gefitinib in combination with cisplatin and radiation (3D-CRT or IMRT) in patients with locally advanced head and neck cancer.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
Inclusion Criteria
- Histologically confirmed head and neck cancer
- Lymph node negative or positive
- Metastasis negative
- Chemo- and radiotherapy naïve
- WHO 0-2
- Measurable disease by RECIST
- Written informed consent
Exclusion Criteria
- Severe alcohol abuse
- Active ILD
- Co-existing chronic gastrointestinal disease(s)
- Brain metastasis
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Parts 1 and 2: Safety (Incidence of DLTs) Part 3: Safety and tolerability
- Secondary Outcome Measures
Name Time Method Parts 2 and 3: Efficacy (Incidence of complete response at 3 months after the end of trial treatment based on RECIST criteria) Exploratory Outcome: EGFR-1 expression, amplification and activation Serum VEGF levels
Trial Locations
- Locations (1)
Research Centre
🇫🇮Helsinki, Finland