RATIONALE: Lapatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

PURPOSE: This phase II trial is studying how well lapatinib works in treating patients with recurrent or metastatic head and neck cancer.

Condition	Intervention	Phase
Hypopharyngeal Cancer Laryngeal Cancer lip and oral cavity cancer Nasopharyngeal Cancer Oropharyngeal Cancer paranasal sinus and nasal cavity cancer	Drug: lapatinib  Procedure: enzyme inhibitor therapy  Procedure: protein tyrosine kinase inhibitor therapy	Phase II

Further Study Details: 

OBJECTIVES: Primary

• Determine the objective response rates (complete response and partial response) in patients with metastatic or recurrent squamous cell carcinoma of the head and neck treated with lapatinib.

Secondary

• Determine time to progression in patients treated with this drug.
• Determine the adverse advent profile of this drug in these patients.

OUTLINE: Patients receive oral lapatinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed at least every 3 months for 1 year.

PROJECTED ACCRUAL: A total of 15-30 patients will be accrued for this study within approximately 1 year.

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

Criteria

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed squamous cell carcinoma of the head and neck of 1 of the following sites:
• Oral cavity
• Oropharynx
• Nasopharynx
• Hypopharynx
• Glottis
• Ethmoid/maxillary sinuses
• Metastatic or recurrent disease
• Localized disease allowed provided disease is refractory to primary radiotherapy, surgery, and/or chemotherapy
• Patients with single site or regional recurrence that is potentially curable by surgical resection or re-irradiation must have declined these therapies
• Measurable disease
• At least 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan
• Tumor accessible for needle biopsy
• 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 > 3,000/mm^3
• Absolute neutrophil count > 1,500/mm^3
• Platelet count > 100,000/mm^3

Hepatic

• Bilirubin normal
• AST and ALT ≤ 2.5 times upper limit of normal

Renal

• Creatinine normal OR
• Creatinine clearance > 60 mL/min

Cardiovascular

• Ejection fraction normal by echocardiogram or MUGA
• No symptomatic congestive heart failure
• No unstable angina pectoris
• No cardiac arrhythmia

Gastrointestinal

• No malabsorption syndrome
• No gastrointestinal (GI) tract disease that would preclude ability to take oral medication
• No requirement for IV alimentation
• No uncontrolled inflammatory GI disease (e.g., Crohn''''s disease or ulcerative colitis)
• Able to retain and absorb medication administered by mouth or feeding tube

Other

• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• No ongoing or active infection
• No other uncontrolled illness
• No history of allergic reaction attributed to compounds of similar chemical or biological composition to lapatinib
• No psychiatric illness or social situation that would preclude study compliance

PRIOR CONCURRENT THERAPY: Biologic therapy

• Not specified

Chemotherapy

• See Disease Characteristics
• At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered
• No more than 2 prior chemotherapy regimens

Endocrine therapy

• At least 14 days since prior and no concurrent dexamethasone or dexamethasone equivalent dose > 1.5 mg/day

Radiotherapy

• See Disease Characteristics
• At least 4 weeks since prior radiotherapy and recovered

Surgery

• See Disease Characteristics
• No prior surgical procedure affecting absorption

Other

• No prior tyrosine kinase inhibitors
• No prior anti-epidermal growth factor receptor- or HER2/neu-targeting therapies
• At least 7 days since prior and no concurrent CYP3A4 inhibitors, including any of the following:
• Clarithromycin
• Erythromycin
• Troleandomycin
• Itraconazole
• Ketoconazole
• Voriconazole
• Fluconazole (doses ≤ 150 mg/day are allowed)
• Nefazodone
• Fluvoxamine
• Verapamil
• Diltiazem
• Cimetidine
• Aprepitant
• Grapefruit or its juice
• Bitter orange
• At least 14 days since prior and no concurrent CYP3A4 inducers, including any of the following:
• Phenytoin
• Carbamazepine
• Phenobarbital
• Rifampin
• Rifabutin
• Rifapentine
• Hypericum perforatum (St. John''''s wort)
• Modafinil
• At least 6 months since prior and no concurrent amiodarone
• At least 7 days since prior and no concurrent H2 inhibitors or proton pump inhibitors
• Concurrent antacids allowed provided they are administered ≥ 1 hour before and after lapatinib administration
• Concurrent oral anticoagulants (e.g., warfarin) allowed provided there is increased vigilance in monitoring INR
• No concurrent combination antiretroviral therapy for HIV-positive patients
• No other concurrent investigational agents
• No other concurrent anticancer therapy

Please refer to this study by ClinicalTrials.gov identifier  NCT00114283

Virginia
      Cancer Center at the University of Virginia, Charlottesville,  Virginia,  22908,  United States; Recruiting

Study chairs or principal investigators

Christopher Y. Thomas, MD,  Principal Investigator,  University of Virginia, Health Sciences Center Cancer Center   

Study ID Numbers:  CDR0000430924; UVACC-HIC-11569; UVACC-33604; NCI-6697; NCT00114283
Record last reviewed:  June 2005
Last Updated:  June 30, 2005
Record first received:  June 13, 2005
ClinicalTrials.gov Identifier:  NCT00114283
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-07-05