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)