Squamous Cell CancerPhase 2NCT00255476
The IRESSA Novel Head and Neck Chemotherapy Evaluation Study
A Phase 2 study testing gefitinib, cisplatin and 5-flourouracil in people with Squamous Cell Cancer and Cancer of Head and Neck, run by AstraZeneca at 1 site in United Kingdom.
Trial summary
The purpose of this study is to compare the objectie tumour response rate between the cisplatin/5FU and cisplatin/5FU plus ZD1839 combination Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Squamous Cell Cancer, Cancer of Head and Neck
- What is being tested?
- gefitinib, cisplatin and 5-flourouracil
- How many people
- 64 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Feb 2004to Jul 2007
- Phase
- Phase 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
- Provision of written informed consent
- Patients with histologically proven primary SCCHN
- Aged 18 or over
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
The purpose of this study is to compare the objectie tumour response rate between the cisplatin/5FU and cisplatin/5FU plus ZD1839 combination
- Conditions
- Squamous Cell Cancer, Cancer of Head and Neck
- Medical subject headings
- Neoplasms, Squamous Cell, 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.
To compare the objective tumour response rate between cisplatin/5FU and cisplatin/5FU and ZD1839 combination in these patients
Secondary outcomes (1)
To compare safety and tolerability in these patients
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2005 (estimated)
- Study startFeb 2004
- Study completionJul 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Squamous Cell CancerStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 64 participants
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- AstraZeneca Iressa Medical Sciences Director, MD, Study director, AstraZeneca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00255476
- Sponsor's protocol ID
- 1839IL/0544
- Status last verified
- Apr 2009
- First submitted
- 17 Nov 2005
- Last updated
- 23 Apr 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00255476
- Acronym / sponsor ID
- 1839IL/0544
- Conditions
- Squamous Cell Cancer, Cancer of Head and Neck
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Feb 2004
- Study completion
- Jul 2007 (actual)
- First posted
- 21 Nov 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.
The purpose of this study is to compare the objectie tumour response rate between the cisplatin/5FU and cisplatin/5FU plus ZD1839 combination
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 (3 listed)
- Provision of written informed consent
- Patients with histologically proven primary SCCHN
- Aged 18 or over
Key exclusion criteria (3 listed)
- 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
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 | – |
| 5-flourouracil | Drug | – |
Primary outcome
To compare the objective tumour response rate between cisplatin/5FU and cisplatin/5FU and ZD1839 combination in these patients
1 secondary outcome
To compare safety and tolerability in these patients
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 23 Apr 2009.
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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 Iressa Medical Sciences 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 2 study testing gefitinib, cisplatin and 5-flourouracil in people with Squamous Cell Cancer and Cancer of Head and Neck, run by AstraZeneca at 1 site in United Kingdom.
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 3 inclusion and 3 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 23 Apr 2009. 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 United Kingdom. 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 phase mean?
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?
To compare the objective tumour response rate between cisplatin/5FU and cisplatin/5FU and ZD1839 combination in these patients. 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 23 Apr 2009.