Head and Neck CancerPhase 1/2NCT00352105
Cisplatin, Fluorouracil, Iressa, and Radiation Therapy Patients With Locally Advanced Head and Neck Cancer
A Phase 1/2 study testing cisplatin, fluorouracil and Iressa in people with Head and Neck Cancer, run by David Adelstein at 1 site in United States.
Trial summary
RATIONALE: Drugs used in chemotherapy, such as cisplatin and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Gefitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer
- What is being tested?
- cisplatin, fluorouracil and Iressa
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2006to May 2010
- Phase
- Phase 1/2
- 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
DISEASE CHARACTERISTICS:
- Histologically confirmed primary* squamous cell carcinoma of the head and neck region, excluding any of the following:
- Nasopharynx
- Paranasal sinuses
- Salivary glands NOTE: *Primary site must be identified
- Locoregionally confined stage III or IV disease
- No evidence of nodal disease below the clavicles
- No distant hematogenous metastases (M0)
PATIENT CHARACTERISTICS:
- ECOG performance status 0-1
- WBC > 3,500/mm³
- Platelet count > 100,000/mm³
- Creatinine ≤ 2.0 mg/dL
- Alkaline phosphatase < 2 times normal
- AST < 2 times normal
- Bilirubin ≤ 2.0 mg/dL
- Calcium normal
- Not pregnant or nursing
- Fertile patients must use effective contraception
- Must not be a poor compliance risk for follow-up
- No known severe hypersensitivity to gefitinib or any excipients of this drug
- No evidence of clinically active interstitial lung disease
- Patients with chronic, stable radiographic changes who are asymptomatic are eligible
- No unstable or uncontrolled angina, clinically apparent jaundice, or active infection
- No history of any other malignancy (except squamous cell or basal cell skin cancer or cervical carcinoma in situ) unless disease free for ≥ 5 years
- No other severe, uncontrolled systemic disease (e.g., unstable or uncompensated respiratory, cardiac, hepatic, or renal disease)
PRIOR CONCURRENT THERAPY:
- Recovered from prior oncologic or other major surgery
- No prior definitive surgery, radiotherapy, chemotherapy, immunotherapy, or epidermal growth factor receptor inhibitors for head and neck cancer
- No investigational drugs within the past 30 days
- No concurrent CYP3A4 inducers, including any of the following:
- Phenytoin
- Carbamazepine
- Rifampin
- Phenobarbital
- Hypericum perforatum (St. John's wort)
- Concurrent surgery allowed provided gefitinib is not administered 2 weeks before and 2 weeks after surgery
- No concurrent aminoglycoside antibiotics
Trial locations and contacts
1 site in 1 country.
United States1 site
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
Cleveland, Ohio, 44195
About this study
Official title: A Phase I/II Trial of Concurrent Chemotherapy and ZD1839 (IRESSA) With Hyperfractionated Radiation Therapy, Followed by Maintenance ZD1839 (IRESSA) for Patients With Locally Advanced Squamous Cell Head and Neck Cancer
RATIONALE: Drugs used in chemotherapy, such as cisplatin and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Gefitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving cisplatin, fluorouracil, and gefitinib together with radiation therapy may kill more tumor cells.
PURPOSE: This phase I/II trial is studying the side effects of giving cisplatin, fluorouracil, and gefitinib together with hyperfractionated radiation therapy and to see how well they work in treating patients with locally advanced head and neck cancer.
Read the detailed description
OBJECTIVES:
Primary
- Explore the activity of cisplatin, fluorouracil, gefitinib, and hyperfractionated radiotherapy, in terms of 1-year survival and 1-year distant metastatic disease control, in patients with locally advanced squamous cell carcinoma of the head and neck.
Secondary
- Explore the activity of this regimen, in terms of disease-specific survival and local control, in these patients.
- Assess the toxicity of this regimen in these patients.
- Assess the complete response rate in patients treated with this regimen.
- Assess the toxicity and tolerability of long-term maintenance with gefitinib in patients rendered disease free after this treatment regimen.
OUTLINE: Patients undergo hyperfractionated radiotherapy twice daily, 5 days a week, beginning on day 1 and continuing for 6 weeks. Patients also receive fluorouracil IV continuously over 96 hours and cisplatin IV continuously over 96 hours on days 1-4 and 22-25 and oral gefitinib beginning once daily on day 1 and continuing for up to 2 years in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 3-6 months.
PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study.
- Conditions
- Head and Neck Cancer
- Being tested
- cisplatin, fluorouracil, Iressa, hyperfractionated radiation therapy
- Keywords
- stage III squamous cell carcinoma of the hypopharynx, stage IV squamous cell carcinoma of the hypopharynx, stage III squamous cell carcinoma of the larynx, stage IV squamous cell carcinoma of the larynx, stage III squamous cell carcinoma of the lip and oral cavity, stage IV squamous cell carcinoma of the lip and oral cavity, stage III squamous cell carcinoma of the oropharynx, stage IV squamous cell carcinoma of the oropharynx
- Medical subject headings
- Head and Neck Neoplasms, Squamous Cell Carcinoma of Head and Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cisplatinDrug
Also called CDDP
20mg/m2/d IV continuous infusion x4 days
fluorouracilDrug
Also called 5FU
1000mg.m2/d IV continuous x 4 days
IressaDrug
Also called ZD1839
250mg/PO qd x 2 years
hyperfractionated radiation therapyRadiation
120cGy bid
| Study group | Role | What they receive |
|---|---|---|
| Concurrent Chemotherapy and ZD1839 | Experimental | Not described Receives: Drug: cisplatin; Drug: fluorouracil; Drug: Iressa; Radiation: hyperfractionated radiation therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients Treated With ZD1839 With Chemotherapy and Hyperfractionated Radiation That Had a 1-year Survival
To explore the activity of ZD1839 with chemotherapy and hyperfractionated radiation using 1-year survival
Measured: at 1 year after start of treatment
Number of Participants With No Distant Metastatic Disease at 1 Year
1-year distant metastatic disease control in patients with locally advanced squamous cell head and neck cancer. Distant disease means that cancer came back in sites outside of the head and neck.
Measured: 1 year
Secondary outcomes (4)
Number of Participants With No Local Disease at 1 Year
Number of Participants with No Local Disease at 1 Year. Local disease means that the cancer came back in the same site.
Measured: at 1 year after start of treatment
Number of Patients With Greater Than or Equal to Mild (Grade 1) Toxicity
Any toxicity greater than or equal to Grade 1= mild
Measured: at 1 year after start of treatment
Number of Patients With a Complete Response Defined as Complete Disappearance of All Clinically Detectable Tumor.
Complete response rate per RECIST Criteria (CTC V3)
Measured: 3 years
Number of Participants Who Completed 2 Years of Therapy
Measured: at 2 years after start of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2006 (estimated)
- Study startApr 2006
- Primary completionSep 2008
- Study completionMay 2010
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 Head and Neck CancerStudies of the same condition, open and under way.
- 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
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- David Adelstein
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor-investigator, David Adelstein, Case Comprehensive Cancer Center
- Investigators
- David J. Adelstein, MD, Study chair, Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00352105
- Sponsor's protocol ID
- CCF5842
- Other IDs
- P30CA043703, CCF-5842, ZENECA-1839/0235
- Status last verified
- Nov 2012
- First submitted
- 13 Jul 2006
- Last updated
- 5 Nov 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Trial of Concurrent Chemotherapy and ZD1839 (IRESSA) With Hyperfractionated Radiation Therapy, Followed by Maintenance ZD1839 (IRESSA) for Patients With Locally Advanced Squamous Cell Head and Neck Cancer
- ClinicalTrials.gov ID
- NCT00352105
- Acronym / sponsor ID
- CCF5842
- Conditions
- Head and Neck Cancer
- Keywords
- stage III squamous cell carcinoma of the hypopharynx, stage IV squamous cell carcinoma of the hypopharynx, stage III squamous cell carcinoma of the larynx, stage IV squamous cell carcinoma of the larynx, stage III squamous cell carcinoma of the lip and oral cavity, stage IV squamous cell carcinoma of the lip and oral cavity, stage III squamous cell carcinoma of the oropharynx, stage IV squamous cell carcinoma of the oropharynx
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- David AdelsteinUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Apr 2006
- Primary completion
- Sep 2008 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 14 Jul 2006 (estimated)
- Results
- Posted 1 Mar 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Drugs used in chemotherapy, such as cisplatin and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Gefitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving cisplatin, fluorouracil, and gefitinib together with radiation therapy may kill more tumor cells.
PURPOSE: This phase I/II trial is studying the side effects of giving cisplatin, fluorouracil, and gefitinib together with hyperfractionated radiation therapy and to see how well they work in treating patients with locally advanced head and neck cancer.
Detailed description
OBJECTIVES:
Primary
- Explore the activity of cisplatin, fluorouracil, gefitinib, and hyperfractionated radiotherapy, in terms of 1-year survival and 1-year distant metastatic disease control, in patients with locally advanced squamous cell carcinoma of the head and neck.
Secondary
- Explore the activity of this regimen, in terms of disease-specific survival and local control, in these patients.
- Assess the toxicity of this regimen in these patients.
- Assess the complete response rate in patients treated with this regimen.
- Assess the toxicity and tolerability of long-term maintenance with gefitinib in patients rendered disease free after this treatment regimen.
OUTLINE: Patients undergo hyperfractionated radiotherapy twice daily, 5 days a week, beginning on day 1 and continuing for 6 weeks. Patients also receive fluorouracil IV continuously over 96 hours and cisplatin IV continuously over 96 hours on days 1-4 and 22-25 and oral gefitinib beginning once daily on day 1 and continuing for up to 2 years in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 3-6 months.
PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Concurrent Chemotherapy and ZD1839 | Experimental | Drug: cisplatin, Drug: fluorouracil, Drug: Iressa, Radiation: hyperfractionated radiation therapy |
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 |
|---|---|---|
| cisplatinAlso: CDDP20mg/m2/d IV continuous infusion x4 days | Drug | Concurrent Chemotherapy and ZD1839 |
| fluorouracilAlso: 5FU1000mg.m2/d IV continuous x 4 days | Drug | Concurrent Chemotherapy and ZD1839 |
| IressaAlso: ZD1839250mg/PO qd x 2 years | Drug | Concurrent Chemotherapy and ZD1839 |
| hyperfractionated radiation therapy120cGy bid | Radiation | Concurrent Chemotherapy and ZD1839 |
Primary outcome
Number of Patients Treated With ZD1839 With Chemotherapy and Hyperfractionated Radiation That Had a 1-year Survival
Time frame: at 1 year after start of treatment
To explore the activity of ZD1839 with chemotherapy and hyperfractionated radiation using 1-year survival
Number of Participants With No Distant Metastatic Disease at 1 Year
Time frame: 1 year
1-year distant metastatic disease control in patients with locally advanced squamous cell head and neck cancer. Distant disease means that cancer came back in sites outside of the head and neck.
4 secondary outcomes
Number of Participants With No Local Disease at 1 Year
Time frame: at 1 year after start of treatment
Number of Patients With Greater Than or Equal to Mild (Grade 1) Toxicity
Time frame: at 1 year after start of treatment
Number of Patients With a Complete Response Defined as Complete Disappearance of All Clinically Detectable Tumor.
Time frame: 3 years
Number of Participants Who Completed 2 Years of Therapy
Time frame: at 2 years after start of treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2012.
- 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.
David J. Adelstein, MD study chair
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
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 cisplatin, fluorouracil and Iressa in people with Head and Neck Cancer, run by David Adelstein 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 5 Nov 2012. 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 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?
Yes. Results are posted in the registry (first posted 1 Mar 2012). 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?
Number of Patients Treated With ZD1839 With Chemotherapy and Hyperfractionated Radiation That Had a 1-year Survival (time frame: at 1 year after start of treatment). 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 5 Nov 2012; AzTrials last refreshed its copy on 8 Nov 2026.