RATIONALE: Biological therapies such as gefitinib may interfere with the growth of tumor cells by blocking an enzyme necessary for cell growth.

PURPOSE: Phase II trial to study the effectiveness of gefitinib in treating patients who have recurrent and/or metastatic head and neck cancer.

Condition	Treatment or Intervention	Phase
Head and Neck Cancer	Drug: gefitinib  Procedure: enzyme inhibitor therapy  Procedure: protein tyrosine kinase inhibitor therapy	Phase II

Further Study Details: 

OBJECTIVES:

• Determine the disease control rate, in terms of complete response, partial response, and stable disease for at least 4 months, in patients with recurrent and/or metastatic squamous cell cancer of the head and neck treated with gefitinib.
• Determine the effect of this drug on epidermal growth factor receptor phosphorylation and expression of selected genes in these patients.
• Determine the toxic effects of this drug in these patients.

OUTLINE: Patients are stratified as delineated in the Disease Characteristics.

Patients receive oral gefitinib daily. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: A total of 50-60 patients (25-30 per stratum) will be accrued for this study within 2 years.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed primary squamous cell cancer of the head and neck that is incurable by surgery or radiotherapy
• Failed surgery and/or radiotherapy and received no prior systemic chemotherapy for recurrent disease OR
• Recurrent disease at least 6 months after prior multimodal primary therapy including neoadjuvant or concurrent chemotherapy OR
• Metastatic disease at initial diagnosis and received no prior chemotherapy
• No more than 1 prior chemotherapy regimen for recurrent disease OR
• Recurrent disease within 6 months after prior primary therapy that included chemotherapy
• Measurable disease
• At least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan
• Clear clinical evidence of progression or biopsy-proven residual cancer required if only site of measurable disease is in a previously irradiated field
• No known brain metastases

PATIENT CHARACTERISTICS: Age:

• 18 and over

Performance status:

• ECOG 0-2 OR
• Karnofsky 60-100%

Life expectancy:

• More than 3 months

Hematopoietic:

• WBC at least 3,000/mm^3
• Absolute neutrophil count at least 1,500/mm^3
• Platelet count at least 100,000/mm^3

Hepatic:

• Bilirubin normal (no greater than 1.5 times upper limit of normal [ULN] if liver metastases present)
• AST/ALT no greater than 2.5 times ULN

Renal:

• Creatinine no greater than 1.5 times ULN OR
• Creatinine clearance at least 60 mL/min

Cardiovascular:

• No symptomatic congestive heart failure
• No unstable angina pectoris
• No cardiac arrhythmia

Other:

• No other malignancy within the past 5 years except curatively treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
• No other uncontrolled concurrent illness
• No ongoing or active infection
• No psychiatric illness or social situation that would preclude study compliance
• No prior allergic reactions attributed to compounds of similar chemical or biologic composition to gefitinib
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy:

• No prior therapy with agents that target epidermal growth factor receptors

Chemotherapy:

• See Disease Characteristics
• At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered

Endocrine therapy:

• No concurrent tamoxifen

Radiotherapy:

• See Disease Characteristics
• Prior radiotherapy as primary or secondary treatment allowed
• At least 4 weeks since prior radiotherapy and recovered

Surgery:

• See Disease Characteristics
• Prior surgery as primary or secondary treatment allowed
• At least 4 weeks since prior major surgery

Other:

• No other concurrent investigational agents
• No concurrent combination antiretroviral therapy for HIV
• No concurrent 3A4 inhibitors (e.g., ketoconazole, erythromycin, verapamil)
• No concurrent drugs with known corneal toxicity (e.g., chlorpromazine, amiodarone, chloroquine)

Utah
      Huntsman Cancer Institute at University of Utah, Salt Lake City,  Utah,  84112,  United States; Recruiting

Study chairs or principal investigators

Richard H. Wheeler, MD,  Study Chair,  University of Utah   

Study ID Numbers:  CDR0000068890; UUMC-8429-01; NCI-1701; NCT00024089
Record last reviewed:  March 2005
Last Updated:  March 10, 2005
Record first received:  September 13, 2001
ClinicalTrials.gov Identifier:  NCT00024089
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08