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
- Are there results?
- None posted in the registry
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
- 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.
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
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00239304
- Acronym / sponsor ID
- 1839IL/0151
- Conditions
- Head and Neck Neoplasms
- Keywords
- Stage III Head and Neck Cancer, Stage IV Head and Neck Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Jun 2003
- Study completion
- Mar 2006 (actual)
- First posted
- 17 Oct 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Histologically confirmed head and neck cancer
- Lymph node negative or positive
- Metastasis negative
- Chemo- and radiotherapy naïve
- WHO 0-2
Key exclusion criteria (4 listed)
- Severe alcohol abuse
- Active ILD
- Co-existing chronic gastrointestinal disease(s)
- Brain metastasis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gefitinib | Drug | – |
| Cisplatin | Drug | – |
| Radiotherapy | Procedure or surgery | – |
Primary outcome
Parts 1 and 2: Safety (Incidence of DLTs)
Part 3: Safety and tolerability
2 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2007.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
AstraZeneca Finland Medical Director, MD study director
AstraZeneca
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Dec 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Parts 1 and 2: Safety (Incidence of DLTs). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2007.