Neoplasms, Squamous CellPhase 2NCT00229723
IRESSA™ (Gefitinib) With Cisplatin Plus Radiotherapy for the Treatment of Previously Untreated Unresected Late Stage III/IV Non-Metastatic Head and Neck Squamous Cell Carcinoma
A Phase 2 study testing gefitinib (Iressa), cisplatin and radiotherapy in people with Neoplasms, Squamous Cell, run by AstraZeneca at 25 sites in 8 countries.
Trial summary
The primary purpose of this study is to assess the effectiveness of ZD1839 250 mg and 500 mg when given either concomitantly or as maintenance to a standard therapy of radiotherapy (X-rays) plus chemotherapy (cisplatin) in terms of local disease control (progression-free) rate at 2 years. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neoplasms, Squamous Cell
- What is being tested?
- gefitinib (Iressa), cisplatin and radiotherapy
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 224 participants
- Where
- 25 sitesin 8 countries
- Study dates
- Nov 2004to Jun 2008
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 or cytologically confirmed stage III or IVA squamous cell carcinoma of the head and neck
- No prior surgery or chemotherapy/biological therapy/radiation therapy
- Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST)
- Life expectancy of more than 12 weeks
Who cannot join
- Cancers of the nasal space, oral cavity and larynx; or certain lung diseases.
- Abnormal blood chemistry; uncontrolled respiratory, cardiac, hepatic, or renal disease; or coexisting malignancies.
Trial locations and contacts
25 sites in 8 countries.
25 sites in 8 countries
Poland5 sites
Research Site
Gliwice
Research Site
Krakow
Research Site
Lodz
Research Site
Lublin
Research Site
Warsaw
Germany4 sites
Research Site
Berlin
Research Site
Essen
Research Site
Münster
Research Site
Saarbrücken
India4 sites
Research Site
Bangalore
Research Site
Mumbai
Research Site
New Delhi
Research Site
Thiruvananthapuram
Czechia3 sites
Research Site
Hradec Králové
Research Site
Pardubice
Research Site
Pilsen
United States2 sites
Research Site
Aurora, Colorado
Research Site
Dallas, Texas
About this study
Official title: A Phase 2 Randomised, Double-Blind, Placebo-Controlled, Multicentre Comparative Study of Gefitinib 250 mg or 500 mg (IRESSA™) Given Either Continuously or Concomitantly With Cisplatin Plus Radiotherapy for the Treatment of Patients With Previously Untreated Unresected Late Stage III/IV Non-Metastatic Head and Neck Squamous Cell Carcinoma
The primary purpose of this study is to assess the effectiveness of ZD1839 250 mg and 500 mg when given either concomitantly or as maintenance to a standard therapy of radiotherapy (X-rays) plus chemotherapy (cisplatin) in terms of local disease control (progression-free) rate at 2 years.
- Conditions
- Neoplasms, Squamous Cell
- Being tested
- gefitinib (Iressa), cisplatin, radiotherapy
- Keywords
- Head and Neck Squamous Cell Carcinoma, Head and Neck Squamous Cell Cancer, Squamous Cell Carcinoma, Squamous Cell Cancer
- Medical subject headings
- Neoplasms, Squamous Cell, Squamous Cell Carcinoma of Head and Neck, Carcinoma, Squamous Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gefitinib (Iressa)Drug
Also called ZD1839, IRESSA
250 mg oral tablet
cisplatinDrug
intravenous infusion
radiotherapyRadiation
radiation therapy
Gefitinib (Iressa)Drug
Also called ZD1839, Iressa
500 mg oral tablet
| Study group | Role | What they receive |
|---|---|---|
| 1 | Placebo comparator | Radiation + cisplatin; followed by placebo as maintenance therapy Receives: Drug: cisplatin; Radiation: radiotherapy |
| 2 | Experimental | 250 mg gefitinib + radiation + cisplatin; followed by placebo as maintenance therapy Receives: Drug: gefitinib (Iressa); Drug: cisplatin; Radiation: radiotherapy |
| 3 | Experimental | 500 mg gefitinib + radiation + cisplatin; followed by placebo as maintenance therapy Receives: Drug: cisplatin; Radiation: radiotherapy; Drug: Gefitinib (Iressa) |
| 4 | Experimental | gefitinib 250 mg + cisplatin + radiotherapy; followed by gefitinib 250 mg as maintenance therapy Receives: Drug: gefitinib (Iressa); Drug: cisplatin; Radiation: radiotherapy |
| 5 | Experimental | gefitinib 500 mg + cisplatin + radiotherapy; followed by gefitinib 500 mg as maintenance therapy Receives: Drug: cisplatin; Radiation: radiotherapy; Drug: Gefitinib (Iressa) |
| 6 | Placebo comparator | placebo + cisplatin + radiotherapy; followed by gefitinib 250 mg as maintenance therapy Receives: Drug: gefitinib (Iressa); Drug: cisplatin; Radiation: radiotherapy |
| 7 | Placebo comparator | placebo + cisplatin + radiotherapy; followed by gefitinib 500 mg as maintenance therapy Receives: Drug: cisplatin; Radiation: radiotherapy; Drug: Gefitinib (Iressa) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Local Disease Control Rate at 2 Years
A patient demonstrated local disease control at 2 years if there was no evidence of failure of treatment. Failure was defined as the patient having objective disease progression (as per RECIST) inside the original irradiated area, at an isodose level (between 20% and 95%), or death.
Measured: Assessed at 2 yrs. Tumour assessments (clinical & by CT/MRI) were carried out during screening & regularly throughout the study until disease progression (as defined by Response evaluation criteria in solid tumours (RECIST)).
Secondary outcomes (6)
Local Disease Control Rate at 1 Year
A patient demonstrated local disease control at 1 year if there was no evidence of failure of treatment. Failure was defined as the patient having objective disease progression (as per RECIST) inside the original irradiated area, at an isodose level (between 20% and 95%), or death.
Measured: Assessed after 1 year. Tumour assessments (clinical and by CT/MRI) were carried out during screening & regularly throughout the study until disease progression (as defined by RECIST).
Complete Response
A patient was deemed to be a complete responder if the RECIST criteria for complete response were satisfied at any time during the study.
Measured: Assessed at 2 years. Clinical tumour assessments and tumour assessment by CT/MRI were carried out during screening and regularly throughout the study until disease progression.
Tumour Response (Complete Response + Partial Response)
A patient was deemed to be have a tumour response if the RECIST criteria for complete response or partial response were satisfied at any time during the study.
Measured: Assessed at 2 years. Clinical tumour assessments and tumour assessment by CT/MRI were carried out during screening and regularly throughout the study until disease progression
Progression Free Survival
Percentage of participants who are progression free at 2 years (calculated using the Kaplan-Meier method, which allows for censored observations for example those lost to follow-up). A patient is said to have progressed if they have progression of target or non-target lesions or evidence of any new lesions (as defined by RECIST).
Measured: Clinical tumour assessments and tumour assessment by CT/MRI were carried out during screening and regularly throughout the study until disease progression (as defined by RECIST)
Overall Survival
Percentage of participants who are alive at 2 years (calculated using the Kaplan-Meier method, which allows for patients who do not have complete follow-up (censored observations)).
Measured: Overall survival assessed at 2 years
Safety and Tolerability
Measured: Assessed over two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2005 (estimated)
- Study startNov 2004
- Study completionJun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Neoplasms, Squamous CellStudies 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
- Factorial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 224 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- AstraZeneca Oncology Medical Science Director, MD, Study director, AstraZeneca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00229723
- Sponsor's protocol ID
- 1839IL/0706
- Other IDs
- EudraCT number 2004-000358-21, D7919C00706
- Status last verified
- Jun 2009
- First submitted
- 28 Sep 2005
- Last updated
- 4 Aug 2009
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Randomised, Double-Blind, Placebo-Controlled, Multicentre Comparative Study of Gefitinib 250 mg or 500 mg (IRESSA™) Given Either Continuously or Concomitantly With Cisplatin Plus Radiotherapy for the Treatment of Patients With Previously Untreated Unresected Late Stage III/IV Non-Metastatic Head and Neck Squamous Cell Carcinoma
- ClinicalTrials.gov ID
- NCT00229723
- Acronym / sponsor ID
- 1839IL/0706
- Conditions
- Neoplasms, Squamous Cell
- Keywords
- Head and Neck Squamous Cell Carcinoma, Head and Neck Squamous Cell Cancer, Squamous Cell Carcinoma, Squamous Cell Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 224 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Nov 2004
- Study completion
- Jun 2008 (actual)
- First posted
- 30 Sep 2005 (estimated)
- Results
- Posted 4 Aug 2009
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary purpose of this study is to assess the effectiveness of ZD1839 250 mg and 500 mg when given either concomitantly or as maintenance to a standard therapy of radiotherapy (X-rays) plus chemotherapy (cisplatin) in terms of local disease control (progression-free) rate at 2 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| 1 | Placebo comparator | Drug: cisplatin, Radiation: radiotherapyRadiation + cisplatin; followed by placebo as maintenance therapy |
| 2 | Experimental | Drug: gefitinib (Iressa), Drug: cisplatin, Radiation: radiotherapy250 mg gefitinib + radiation + cisplatin; followed by placebo as maintenance therapy |
| 3 | Experimental | Drug: cisplatin, Radiation: radiotherapy, Drug: Gefitinib (Iressa)500 mg gefitinib + radiation + cisplatin; followed by placebo as maintenance therapy |
| 4 | Experimental | Drug: gefitinib (Iressa), Drug: cisplatin, Radiation: radiotherapygefitinib 250 mg + cisplatin + radiotherapy; followed by gefitinib 250 mg as maintenance therapy |
| 5 | Experimental | Drug: cisplatin, Radiation: radiotherapy, Drug: Gefitinib (Iressa)gefitinib 500 mg + cisplatin + radiotherapy; followed by gefitinib 500 mg as maintenance therapy |
| 6 | Placebo comparator | Drug: gefitinib (Iressa), Drug: cisplatin, Radiation: radiotherapyplacebo + cisplatin + radiotherapy; followed by gefitinib 250 mg as maintenance therapy |
| 7 | Placebo comparator | Drug: cisplatin, Radiation: radiotherapy, Drug: Gefitinib (Iressa)placebo + cisplatin + radiotherapy; followed by gefitinib 500 mg as maintenance therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Histologically or cytologically confirmed stage III or IVA squamous cell carcinoma of the head and neck
- No prior surgery or chemotherapy/biological therapy/radiation therapy
- Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST)
- Life expectancy of more than 12 weeks
Key exclusion criteria (2 listed)
- Cancers of the nasal space, oral cavity and larynx; or certain lung diseases.
- Abnormal blood chemistry; uncontrolled respiratory, cardiac, hepatic, or renal disease; or coexisting malignancies.
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 (Iressa)Also: ZD1839, IRESSA250 mg oral tablet | Drug | 2, 4, 6 |
| cisplatinintravenous infusion | Drug | 1, 2, 3, 4, 5, 6, 7 |
| radiotherapyradiation therapy | Radiation | 1, 2, 3, 4, 5, 6, 7 |
| Gefitinib (Iressa)Also: ZD1839, Iressa500 mg oral tablet | Drug | 3, 5, 7 |
Primary outcome
Local Disease Control Rate at 2 Years
Time frame: Assessed at 2 yrs. Tumour assessments (clinical & by CT/MRI) were carried out during screening & regularly throughout the study until disease progression (as defined by Response evaluation criteria in solid tumours (RECIST)).
A patient demonstrated local disease control at 2 years if there was no evidence of failure of treatment. Failure was defined as the patient having objective disease progression (as per RECIST) inside the original irradiated area, at an isodose level (between 20% and 95%), or death.
6 secondary outcomes
Local Disease Control Rate at 1 Year
Time frame: Assessed after 1 year. Tumour assessments (clinical and by CT/MRI) were carried out during screening & regularly throughout the study until disease progression (as defined by RECIST).
Complete Response
Time frame: Assessed at 2 years. Clinical tumour assessments and tumour assessment by CT/MRI were carried out during screening and regularly throughout the study until disease progression.
Tumour Response (Complete Response + Partial Response)
Time frame: Assessed at 2 years. Clinical tumour assessments and tumour assessment by CT/MRI were carried out during screening and regularly throughout the study until disease progression
Progression Free Survival
Time frame: Clinical tumour assessments and tumour assessment by CT/MRI were carried out during screening and regularly throughout the study until disease progression (as defined by RECIST)
Overall Survival
Time frame: Overall survival assessed at 2 years
Safety and Tolerability
Time frame: Assessed over two years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2009.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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 Oncology Medical Science Director, MD study director
AstraZeneca
25 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing gefitinib (Iressa), cisplatin and radiotherapy in people with Neoplasms, Squamous Cell, run by AstraZeneca at 25 sites in 8 countries.
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 4 inclusion and 2 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 4 Aug 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in Poland, Germany, India, Belgium, Czechia and 3 more countries. 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 4 Aug 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Local Disease Control Rate at 2 Years (time frame: Assessed at 2 yrs. Tumour assessments (clinical & by CT/MRI) were carried out during screening & regularly throughout the study until disease progression (as defined by Response evaluation criteria in solid tumours (RECIST)).). 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 4 Aug 2009.