Head and Neck CancerPhase 1NCT00185835
Cisplatin and ZD1839 + Re-Irradiation in Recurrent Squamous Cell Cancer of the Head and Neck
A Phase 1 study testing ZD-1839 and Cisplatin in people with Head and Neck Cancer and Carcinoma, Squamous Cell, run by Stanford University at 1 site in United States.
Trial summary
To determine safety profile of the epidermal growth factor receptor (EGFR) antagonist, ZD1839 in combination with cisplatin and radiation therapy in patients with local-regional recurrent squamous cell cancer of the head and neck. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer, Carcinoma, Squamous Cell
- What is being tested?
- ZD-1839 and Cisplatin
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2002to Jul 2006
- Phase
- Phase 1
- 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
Inclusion Criteria:- Patients must have pathologically confirmed recurrence (reappearance of previously cleared) squamous cell cancer primary in the upper aerodigestive tract or a second squamous cell primary (excluding nasopharynx or salivary gland tumors). Patients may have experienced more than one recurrence as long as the first recurrence occurred greater than or equal to 6 months following the end of the prior RT.
- The recurrence or second primary must have defined bi- or uni-dimensional measurements.
- Recurrence or second primary must be confined to the head and neck above the clavicles (loco-regional recurrence).
- The patient must not be a candidate for complete surgical resection. The previous irradiation must not exceed a maximum of 75 Gy.
- The entire tumor volume must be included in a treatment field that limits the total spinal cord dose to 50 Gy (prior RT and anticipated RT).
- Patients must be at least 6 months from prior radiation therapy.
- Patients may have received prior chemotherapy as a component of their primary treatment, but not for recurrent disease.
- Zubrod performance status 0-1.
- Granulocytes greater than or equal to 1500/mm3, platelets greater than or equal to 100,000/mm3, serum bilirubin less than or equal to 1.5 mg/dl, creatinine less than or equal to 1.5 mg/dl within 2 weeks prior to registration.
- LFT's less than or equal to 2 x normal (SGOT/SGPT/Alkaline Phosphatase). If greater than 2 x normal, liver ultrasound or CT is required to exclude metastases. If negative for metastases, patients are eligible.
- Must be able to submit previous radiation records, including simulation and portal films, in order to assure that cord tolerance is not exceeded.
- Patients must sign a study-specific informed consent form prior to study entry. Exclusion Criteria:- Primary in the nasopharynx or the salivary gland.
- Intercurrent medical illnesses which would impair patient tolerance to therapy or limit survival.
- A history of allergic reactions attributed to compounds of similar chemical or biologic composition to ZD1839 or other agents used in study.
- Pregnant and nursing women are excluded because of the potential teratogenic effects and potential unknown effects on nursing newborns.
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University School of Medicine
Stanford, California, 94305
About this study
Official title: Phase I Study of Cisplatin And ZD1839 (IRESSA®) in Combination With Concomitant Re-Irradiation in Patients With Loco-Regional Recurrent Squamous Cell Cancer of the Head and Neck
To determine safety profile of the epidermal growth factor receptor (EGFR) antagonist, ZD1839 in combination with cisplatin and radiation therapy in patients with local-regional recurrent squamous cell cancer of the head and neck.
To study the effects of ZD1839 combined with either cisplatin or radiotherapy on signal transduction pathway gene expression in tumor cells in patients with local-regional recurrent squamous cell cancer of the head and neck using micro array analysis from tumor samples taken at the time of relapse and during treatment.
- Conditions
- Head and Neck Cancer, Carcinoma, Squamous Cell
- Being tested
- ZD-1839, Cisplatin
- Medical subject headings
- Head and Neck Neoplasms, Carcinoma, Squamous Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZD-1839Drug
CisplatinDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine safety profile of the epidermal growth factor receptor (EGFR) antagonist, ZD 1839 in combination with cisplatin and radiation therapy in patients with local-regional recurrent squamous cell cancer of the head and neck
Measured: no known
Secondary outcomes (5)
To estimate the median and one-year disease-free and overall survival rates of the treated patients.
Measured: one year
To determine the response rate, duration of response and duration of stable disease in these treated patients.
To identify and estimate the incidence rate of acute and late toxicities associated with combined ZD1839, chemotherapy and re-irradiation in patients with recurrent squamous cell cancer of the head and neck.
Measured: no known
To determine the pattern of disease progression in recurrent disease patients treated with this regimen.
To assay EGFR pathway-related proteins by IHC and cDNA microarray, and to correlate their baseline expression, as well as changes in expression after therapy, with clinical endpoints including tumor remission and one-year survival.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startJun 2002
- Primary completionJul 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 CancerStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- American Society of Clinical Oncology, AstraZeneca
- Investigators
- Quynh-Thu Le, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00185835
- Sponsor's protocol ID
- ENT0012
- Other IDs
- ENT0012, NCT00185835
- Status last verified
- Mar 2010
- First submitted
- 12 Sep 2005
- Last updated
- 29 Mar 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study of Cisplatin And ZD1839 (IRESSA®) in Combination With Concomitant Re-Irradiation in Patients With Loco-Regional Recurrent Squamous Cell Cancer of the Head and Neck
- ClinicalTrials.gov ID
- NCT00185835
- Acronym / sponsor ID
- ENT0012
- Conditions
- Head and Neck Cancer, Carcinoma, Squamous Cell
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- American Society of Clinical Oncology, AstraZeneca
- Study start
- Jun 2002
- Primary completion
- Jul 2006 (actual)
- First posted
- 16 Sep 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 safety profile of the epidermal growth factor receptor (EGFR) antagonist, ZD1839 in combination with cisplatin and radiation therapy in patients with local-regional recurrent squamous cell cancer of the head and neck.
To study the effects of ZD1839 combined with either cisplatin or radiotherapy on signal transduction pathway gene expression in tumor cells in patients with local-regional recurrent squamous cell cancer of the head and neck using micro array analysis from tumor samples taken at the time of relapse and during treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- 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
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 |
|---|---|---|
| ZD-1839 | Drug | – |
| Cisplatin | Drug | – |
Primary outcome
To determine safety profile of the epidermal growth factor receptor (EGFR) antagonist, ZD 1839 in combination with cisplatin and radiation therapy in patients with local-regional recurrent squamous cell cancer of the head and neck
Time frame: no known
5 secondary outcomes
To estimate the median and one-year disease-free and overall survival rates of the treated patients.
Time frame: one year
To determine the response rate, duration of response and duration of stable disease in these treated patients.
To identify and estimate the incidence rate of acute and late toxicities associated with combined ZD1839, chemotherapy and re-irradiation in patients with recurrent squamous cell cancer of the head and neck.
Time frame: no known
To determine the pattern of disease progression in recurrent disease patients treated with this regimen.
To assay EGFR pathway-related proteins by IHC and cDNA microarray, and to correlate their baseline expression, as well as changes in expression after therapy, with clinical endpoints including tumor remission and one-year survival.
Time frame: one year
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 29 Mar 2010.
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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.
Quynh-Thu Le principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ZD-1839 and Cisplatin in people with Head and Neck Cancer and Carcinoma, Squamous Cell, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 29 Mar 2010. 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 States. 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 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.
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 determine safety profile of the epidermal growth factor receptor (EGFR) antagonist, ZD 1839 in combination with cisplatin and radiation therapy in patients with local-regional recurrent squamous cell cancer of the head and neck (time frame: no known). 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 29 Mar 2010.