Bevacizumab, Docetaxel, and Radiation Therapy in Treating Patients With Stage III or Stage IV Head and Neck Cancer

OBJECTIVES:

Primary

• Determine the time to progression in patients with stage III or IV squamous cell carcinoma of the head and neck treated with bevacizumab in combination with docetaxel and radiotherapy.

Secondary

• Compare the objective response rate, locoregional control rate, duration of response, patterns of failure, and overall survival of patients treated with this regimen.
• Determine the toxicity of this regimen in these patients.

OUTLINE: Patients undergo radiotherapy once daily, 5 days a week, for 8 weeks and receive docetaxel IV over 1 hour once a week for 8 weeks. Patients also receive bevacizumab IV over 30-90 minutes once every 2 weeks for up to 1 year.

Approximately 8-10 weeks after the completion of chemoradiotherapy, patients may undergo neck dissection. Bevacizumab, which stops 8 weeks before surgery, may restart 4 weeks after surgery and continue for 9 months in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed periodically.

PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed squamous cell carcinoma of the head and neck

• Stage III or IV disease

• No evidence of distant metastases
• No salivary gland or paranasal sinus squamous cell carcinoma
• No disease with close proximity to a major vessel
• Measurable disease
• No known CNS or brain metastases

• Patients with intracranial extension without cerebral involvement may be eligible

PATIENT CHARACTERISTICS:

• ECOG performance status 0-1
• Life expectancy > 12 weeks
• Absolute neutrophil count ≥ 1,500/mm^3
• Platelet count ≥ 100,000/mm^3
• Hemoglobin ≥ 10 g/dL
• Bilirubin normal
• AST and ALT ≤ 2 times upper limit of normal
• PT normal
• Creatinine normal OR
• Creatinine clearance ≥ 60 mL/min
• Urine protein: creatinine ratio < 1.0
• No bleeding diathesis or coagulopathy
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• No history of allergic reaction attributed to compounds of similar chemical or biological composition to study drugs
• No pre-existing peripheral neuropathy ≥ grade 2
• No ongoing or active infection
• No serious non-healing wound, ulcer, or bone fracture
• No New York Heart Association class II-IV congestive heart failure
• No significant arrhythmias requiring medication
• No myocardial infarction within the past 6 months
• No stroke within the past 6 months
• No symptomatic coronary artery disease
• No second- or third-degree heart block or bundle branch block
• No unstable angina pectoris
• No hypertension (i.e., blood pressure ≥ 150/100 mm Hg)
• No other clinically significant heart disease
• No significant traumatic injury within the past 4 weeks
• No psychiatric illness or social situation that would preclude study compliance
• No HIV positivity
• No other malignancy within the past 5 years except squamous cell or basal cell skin cancer or carcinoma in situ of the cervix
• No other uncontrolled illness
• No poorly compliant patients

PRIOR CONCURRENT THERAPY:

• No prior chemotherapy or radiotherapy
• No prior investigational anticancer agents
• More than 4 weeks since prior major surgery
• More than 1 week since prior minor surgery, fine-needle aspiration, or core needle biopsy
• No concurrent major surgery except planned neck dissection
• No concurrent routine colony-stimulating factor therapy
• No other concurrent investigational agents
• No other concurrent anticancer therapy