Erlotinib Plus Docetaxel in Treating Patients With Locally Advanced, Metastatic, or Recurrent Head and Neck Cancer

Inclusion Criteria:

• Histologically or cytologically confirmed squamous cell carcinoma of the head and neck meeting 1 of the following staging criteria:

  • Recurrent
  • Metastatic
  • Locally advanced and determined to be incurable by surgery or radiotherapy
• Measurable disease
• No known brain metastases
• Performance status - ECOG 0-2
• Performance status - Karnofsky 60-100%
• WBC at least 3,000/mm^3
• Absolute neutrophil count at least 1,500/mm^3
• Platelet count at least 100,000/mm^3
• 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 symptomatic congestive heart failure
• No unstable angina pectoris
• No cardiac arrhythmia
• No severe pulmonary insufficiency, including chronic obstructive pulmonary disease, requiring oxygen (O2 saturation less than 90%) and/or increase in PaCO2 blood gas level greater than 50 mm Hg
• No history of abnormality of the cornea (e.g., dry eye syndrome or Sjögren's syndrome)
• No congenital abnormality (e.g., Fuch's dystrophy)
• No abnormal slit-lamp examination using a vital dye (e.g., fluorescein or Bengal-Rose)
• No abnormal corneal sensitivity test (Schirmer test or similar tear production test)
• Able to take oral medication
• No requirement for IV alimentation
• No active peptic ulcer disease
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• No significant traumatic injury within the past 21 days
• No prior allergic reactions to compounds of similar chemical or biological composition to study drugs
• No grade 2 or greater persistent peripheral neuropathy
• No other concurrent uncontrolled illness that would preclude study participation
• No ongoing or active infection
• No psychiatric illness or social situation that would preclude study compliance
• No prior immunotherapy for head and neck cancer
• No more than 1 prior chemotherapy regimen in the adjuvant or neoadjuvant setting
• No more than 1 prior chemotherapy regimen for metastatic disease
• No prior docetaxel (phase II only)
• More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered
• No prior hormonal therapy for head and neck cancer
• Prior external beam radiotherapy allowed
• At least 4 weeks since prior radiotherapy and recovered
• More than 21 days since prior major surgery
• No prior surgery affecting gastrointestinal absorption
• No prior epidermal growth factor receptor-targeting therapy
• No other concurrent investigational agents
• No other concurrent anticancer therapies or agents
• No concurrent combination antiretroviral therapy for HIV-positive patients