Docetaxel, Cisplatin, and Fluorouracil Followed By Cetuximab and Radiation Therapy in Treating Patients With Locally Advanced Head and Neck Cancer

Inclusion:

• Histologically confirmed (from primary lesion and/or lymph nodes) squamous cell carcinoma (SCC) of the head and neck, including the following subtypes:

  • Oropharynx
  • Hypopharynx
  • Larynx

• Primary site of tumor must not include any of the following:

  • Nasopharynx
  • Sinuses
  • Salivary glands
• Stage III or IV disease that is unresectable (oropharynx, larynx, or hypopharynx) OR that is resectable with organ-sparing goal (oropharynx or hypopharynx)
• Measurable disease by CT scan or MRI
• No definitive evidence of distant metastasis
• ECOG performance status 0-1
• ANC ≥ 1,500/μL
• Platelet count ≥ 100,000/μL
• Hemoglobin ≥ 8 g/dL

• Total bilirubin ≤ normal

  • Except in the case where the elevated total bilirubin is not a sign of liver disease (i.e., Gilbert syndrome), in which case a total bilirubin ≤ 2 times upper limit of normal (ULN) is allowed provided direct bilirubin is ≤ ULN

• AST, ALT, and alkaline phosphate (AP) meeting the following criteria:

  • AP normal AND AST or ALT ≤ 5 times upper limit of normal (ULN)
  • AP ≤ 2.5 times ULN AND AST or ALT ≤ 1.5 times ULN
  • AP ≤ 5 times ULN AND AST or ALT normal
• Creatinine ≤ 1.5 mg/dL
• Negative pregnancy test (for women of childbearing potential)
• Fertile patients must use effective contraception during and for ≥ 3 months after completion of study treatment
• Willing to undergo laryngoscopy with biopsy of residual tumor at primary site (as part of a comprehensive evaluation of tumor response after completion of the induction chemotherapy portion of study treatment)

Exclusion:

• History of severe hypersensitivity reaction to docetaxel or to other drugs formulated with polysorbate 80
• Other invasive malignancy within the past 3 years, except nonmelanoma skin cancer
• Prior allergic reaction to the study drug(s)

• Concurrent uncontrolled illness including, but not limited to, any of the following:

  • Ongoing or active infection
  • Psychiatric illness/social situation that would limit compliance with study requirements

  • Significant history of uncontrolled cardiac disease, including any of the following:

    • Uncontrolled hypertension
    • Unstable angina
    • Myocardial infarction within the past 6 months
    • Uncontrolled congestive heart failure
    • Cardiomyopathy with decreased left ventricular ejection fraction (i.e., LVEF < 45%)
• Uncontrolled condition that, in the opinion of the investigator, would interfere in the safe and timely completion of study procedures
• History of interstitial lung disease (e.g., pneumonitis or pulmonary fibrosis) or evidence of interstitial lung disease on screening chest CT scan
• HIV positivity
• Pregnant or nursing
• Prior chemotherapy for the study cancer
• Prior radiotherapy to the region of the study cancer that would result in overlap of radiotherapy fields
• Prior chemotherapy, biological therapy, or hormone therapy within the last one year
• Prior initial surgical treatment, except diagnostic biopsy of the primary site or nodal sampling of neck disease
• Prior radical or modified neck dissection
• Prior therapy that specifically and directly targets the EGFR pathway
• Concurrent investigational agents