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
18 Years
N/A
Both
Head and Neck Cancer
Trial Information
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
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.
Inclusion Criteria
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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Number of Patients Treated With ZD1839 With Chemotherapy and Hyperfractionated Radiation That Had a 1-year Survival
Outcome Description:
To explore the activity of ZD1839 with chemotherapy and hyperfractionated radiation using 1-year survival
Outcome Time Frame:
at 1 year after start of treatment
Safety Issue:
No
Principal Investigator
David J. Adelstein, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
Authority:
United States: Food and Drug Administration
Study ID:
CCF5842
NCT ID:
NCT00352105
Start Date:
April 2006
Completion Date:
May 2010
Related Keywords:
- Head and Neck Cancer
- 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
- Head and Neck Neoplasms
Name | Location |
|---|---|
| Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center | Cleveland, Ohio 44195 |
