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