Head and Neck NeoplasmsPhase 1/2NCT00239304
Gefitinib (Iressa) in Combo With Chemoradiation in Patients With Locally Advanced Head & Neck Cancer
A Phase 1/2 study testing Gefitinib, Cisplatin and Radiotherapy in people with Head and Neck Neoplasms, run by AstraZeneca at 1 site in Finland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Neoplasms
- What is being tested?
- Gefitinib, Cisplatin and Radiotherapy
- Type of treatment
- Surgery or procedure
- How many people
- 40 participants
- Where
- 1 siteFinland
- Study dates
- Jun 2003to Mar 2006
- Phase
- Phase 1/2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Severe alcohol abuse
- Active ILD
- Co-existing chronic gastrointestinal disease(s)
- Brain metastasis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I/II Trial of ZD1839 (Iressa) Given Concurrently With Cisplatin and Radiotherapy in Patients With Locally Advanced Head and Neck Cancer
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.
- Conditions
- Head and Neck Neoplasms
- Being tested
- Gefitinib, Cisplatin, Radiotherapy
- Keywords
- Stage III Head and Neck Cancer, Stage IV Head and Neck Cancer
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GefitinibDrug
CisplatinDrug
RadiotherapyProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Parts 1 and 2: Safety (Incidence of DLTs)
Part 3: Safety and tolerability
Secondary outcomes (2)
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2005 (estimated)
- Study startJun 2003
- Study completionMar 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck NeoplasmsStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- AstraZeneca Finland Medical Director, MD, Study director, AstraZeneca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00239304
- Sponsor's protocol ID
- 1839IL/0151
- Status last verified
- Dec 2007
- First submitted
- 13 Oct 2005
- Last updated
- 18 Dec 2007
- Results posted
- No