Bevacizumab and Erlotinib in Treating Patients With Recurrent or Metastatic Head and Neck Cancer

Inclusion Criteria

• •Histologically or cytologically confirmed squamous cell cancer of the head and neck
• •* Recurrent or metastatic disease
• •* Determined to be incurable by surgery or radiotherapy
• •Measurable disease
• •No tumor involvement encasing or too close in proximity to a major artery or vein
• •No known brain metastases
• •No prior or concurrent CNS disease
• •No primary brain tumor
• •Performance status - ECOG 0-2
• •Performance status - Karnofsky 60-100%
• •More than 12 weeks
• •No history of bleeding diathesis
• •WBC at least 3,000/mm\^3
• •Absolute neutrophil count at least 1,500/mm\^3
• •Platelet count at least 100,000/mm\^3
• •INR less than 1.5
• •Bilirubin normal
• •AST and ALT no greater than 2.5 times upper limit of normal
• •Creatinine normal
• •Creatinine clearance at least 60 mL/min
• •No significant renal impairment
• •24-hour urinary protein less than 0.5 g required if more than trace proteinuria at baseline
• •No uncontrolled hypertension
• •No symptomatic congestive heart failure
• •No serious cardiac arrhythmia requiring medication
• •No deep venous thrombosis
• •No prior stroke
• •No New York Heart Association class II-IV heart disease
• •No grade II-IV peripheral vascular disease within the past year
• •No arterial thromboembolic event within the past 6 months, including any of the following:
• •* Unstable angina pectoris
• •* Myocardial infarction
• •* Transient ischemic attack
• •* Cerebrovascular accident
• •No clinically significant peripheral artery disease
• •No significant ophthalmologic abnormalities\* including any of the following:
• •* Severe dry eye syndrome
• •* Keratoconjunctivitis sicca
• •* Sjögren's syndrome
• •* Severe exposure keratopathy
• •* Disorders that might increase the risk for epithelium-related complications (e.g., bullous keratopathy, aniridia, severe chemical burns, neutrophilic keratitis)
• •Not pregnant or nursing
• •Negative pregnancy test
• •Fertile patients must use effective contraception
• •No prior allergic reactions to compounds of similar chemical or biologic composition to bevacizumab or other study agents
• •No known hypersensitivity to Chinese hamster ovary cell products or other recombinant human antibodies
• •No significant traumatic injury within the past 28 days
• •No other concurrent uncontrolled illness
• •No psychiatric illness or social situation that would preclude study compliance
• •No ongoing or active infection requiring parenteral antibiotics
• •No serious non-healing wound ulcer or bone fracture
• •No seizures not controlled by standard medical therapy
• •More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin)
• •More than 4 weeks since prior radiotherapy
• •More than 4 weeks since prior major surgery
• •More than 4 weeks since prior open biopsy
• •Recovered from prior therapy
• •No more than 1 prior regimen for recurrent disease
• •No prior epidermal growth factor receptor (EGFR)-based therapy for recurrent disease
• •No prior vascular EGFR-based therapy for recurrent disease
• •No other concurrent investigational agents
• •No other concurrent anticancer agents or therapies
• •No concurrent combination antiretroviral therapy for HIV-positive patients
• •No concurrent chronic use of aspirin (325 mg/day or more) or other nonsteroidal anti-inflammatory drugs
• •No concurrent warfarin or heparin, including low-molecular weight heparin
• •No other concurrent or recent (within 1 month) thrombolytic agents or full-dose anticoagulants (except to maintain patency of preexisting, permanent indwelling IV catheters)