Cancer of Head and NeckPhase 2NCT00242749
IRESSA in Combination With Cisplatin & Radiotherapy in Patients With Advanced Head & Neck Carcinoma
A Phase 2 study testing Gefitinib, Cisplatin and Radiotherapy in people with Cancer of Head and Neck, run by AstraZeneca at 4 sites in Spain.
Trial summary
· To evaluate the disease free survival rate at 2 years of patients with advanced head and neck carcinoma treated with ZD1839 250 mg administered once daily in combination with cisplatin and a standard course of radiotherapy. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Cancer of Head and Neck
- What is being tested?
- Gefitinib, Cisplatin and Radiotherapy
- How many people
- 47 participants
- Where
- 4 sitesSpain
- Study dates
- Dec 2002to 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed squamous head and neck carcinoma
- Extra-laryngeal tumour or laryngeal tumour that is inoperable (not resectable) considered by Head and Neck Cancer Committee
- Stage III-IV (IVa and IVb) disease
- Measurable disease according to RECIST criteria
- Aged 18 years or older
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1
- Normal renal, haematological (neutrophils >1´5 x 109/ L and platelets > 100 x 109/L) and liver function
Who cannot join
- 1. Previous treatment for initial disease (neck dissection in N3 is allowed) 2. Other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical cancer in situ 3. Incomplete healing from previous oncologic or other surgery 4. Absolute neutrophil count (ANC) less than 1.5 x 109/ L, or platelets less than 100x 109/L 5. Serum bilirubin greater than 1.25 times the upper limit of reference range (ULRR) 6. In the opinion of the investigator, any evidence of severe or uncontrolled systemic disease (e.g. unstable or uncompensated respiratory, cardiac, hepatic or renal disease) 7. Serum creatinine greater than 1.25 times the ULRR 8. ALT or AST greater than 2.5 times the ULRR 9. Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the patient to participate in the trial 10. Active dermatoses (e.g. psoriasis, eczema) 11. Corneal abnormalities (other than scars, congenital abnormality or corneal tear film), history of dry eye syndrome or ocular surface diseases and neurological disorders 12. Concomitant use of phenytoin, carbamazepine, barbiturates, rifampicin or drugs with known corneal toxicity 13. Pregnancy or breastfeeding (women of child-bearing potential) 14. Patient incapacity to reliably follow the treatment or follow up for family, economic or geographical reasons.
Trial locations and contacts
4 sites in 1 country.
Spain4 sites
Research Site
Badalona
Research Site
Málaga
Research Site
Murcia
Research Site
Santander
About this study
Official title: A Phase 2 Trial to Evaluate ZD1839 (IRESSA) in Combination With Cisplatin & Radiotherapy in Patients With Advanced Head & Neck Carcinoma (Unresectable &Inoperable)
- To evaluate the disease free survival rate at 2 years of patients with advanced head and neck carcinoma treated with ZD1839 250 mg administered once daily in combination with cisplatin and a standard course of radiotherapy.
- Conditions
- Cancer of Head and Neck
- Being tested
- Gefitinib, Cisplatin and Radiotherapy
- Keywords
- Head and Neck Cancer Disease, Head Cancer, Neck Cancer, Cancer of Head, Cancer of Neck, Cancer of the Head, Cancer of the Head and Neck, Cancer of the Neck, Neoplasms, Head and Neck
- 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.
Gefitinib, Cisplatin and RadiotherapyDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease-free survival at 2 years
Secondary outcomes (4)
Objective tumour response (CR and PR) at 6 months after the start of treatment based on the Response Evaluation Criteria in Solid Tumours (RECIST) criteria
PFS
Nature, incidence and severity of adverse events (AEs)
Overall survival
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2005 (estimated)
- Study startDec 2002
- Study completionJul 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer of Head and NeckStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 47 participants
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- AstraZeneca Spain Medical Director, MD, Study director, AstraZeneca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00242749
- Sponsor's protocol ID
- 1839IL/0102
- Status last verified
- Apr 2009
- First submitted
- 20 Oct 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 Phase 2 Trial to Evaluate ZD1839 (IRESSA) in Combination With Cisplatin & Radiotherapy in Patients With Advanced Head & Neck Carcinoma (Unresectable &Inoperable)
- ClinicalTrials.gov ID
- NCT00242749
- Acronym / sponsor ID
- 1839IL/0102
- Conditions
- Cancer of Head and Neck
- Keywords
- Head and Neck Cancer Disease, Head Cancer, Neck Cancer, Cancer of Head, Cancer of Neck, Cancer of the Head, Cancer of the Head and Neck, Cancer of the Neck
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Dec 2002
- Study completion
- Jul 2007 (actual)
- First posted
- 21 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 evaluate the disease free survival rate at 2 years of patients with advanced head and neck carcinoma treated with ZD1839 250 mg administered once daily in combination with cisplatin and a standard course of radiotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Histologically confirmed squamous head and neck carcinoma
- Extra-laryngeal tumour or laryngeal tumour that is inoperable (not resectable) considered by Head and Neck Cancer Committee
- Stage III-IV (IVa and IVb) disease
- Measurable disease according to RECIST criteria
- Aged 18 years or older
Key exclusion criteria (1 listed)
- 1. Previous treatment for initial disease (neck dissection in N3 is allowed) 2. Other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical cancer in situ 3. Incomplete healing from previous oncologic or other surgery 4. Absolute neutrophil count (ANC) less than 1.5 x 109/ L, or platelets less than 100x 109/L 5. Serum bilirubin greater than 1.25 times the upper limit of reference range (ULRR) 6. In the opinion of the investigator, any evidence of severe or uncontrolled systemic disease (e.g. unstable or uncompensated respiratory, cardiac, hepatic or renal disease) 7. Serum creatinine greater than 1.25 times the ULRR 8. ALT or AST greater than 2.5 times the ULRR 9. Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the patient to participate in the trial 10. Active dermatoses (e.g. psoriasis, eczema) 11. Corneal abnormalities (other than scars, congenital abnormality or corneal tear film), history of dry eye syndrome or ocular surface diseases and neurological disorders 12. Concomitant use of phenytoin, carbamazepine, barbiturates, rifampicin or drugs with known corneal toxicity 13. Pregnancy or breastfeeding (women of child-bearing potential) 14. Patient incapacity to reliably follow the treatment or follow up for family, economic or geographical reasons.
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, Cisplatin and Radiotherapy | Drug | – |
Primary outcome
Disease-free survival at 2 years
4 secondary outcomes
Objective tumour response (CR and PR) at 6 months after the start of treatment based on the Response Evaluation Criteria in Solid Tumours (RECIST) criteria
PFS
Nature, incidence and severity of adverse events (AEs)
Overall survival
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 Spain Medical Director, MD study director
AstraZeneca
4 sites 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 Radiotherapy in people with Cancer of Head and Neck, run by AstraZeneca at 4 sites in Spain.
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 1 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 4 sites in Spain. 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?
Disease-free survival at 2 years. 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; AzTrials last refreshed its copy on 8 Nov 2026.