Intervention: FOLFIRI regimen
Trial phase: Phase 2
SMILES: CCc1c2c(nc3ccc(OC(=O)N4CCC(N5CCCCC5)CC4)cc13)-c1cc3c(c(=O)n1C2)COC(=O)C3(O)CC.Nc1nc2c(c(=O)[nH]1)N(C=O)C(CNc1ccc(C(=O)NC(CCC(=O)O)C(=O)O)cc1)CN2.O=c1[nH]cc(F)c(=O)[nH]1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 7
Group description: Single arm Phase II Study Induction Chemo then Concurrent Chemoradiotherapy with Cetuximab in Locally Advanced Head and Neck Squamous Cell Cancer

Cetuximab: Single arm phase II study of chemotherapy
Eligibility criteria:
Inclusion Criteria:

Adult patients 18 years and older with histologically proven locally advanced stage III or IV unresectable Squamous cell head and neck cancer SCCHN (including cancers of oral cavity, oropharynx, larynx and hypopharynx) with no evidence of distant metastasis

A careful evaluation for resection is required from the surgeon and criteria for unresectability carefully defined for individual primary sites as follows:

Hypopharynx: The tumor must extend across the midline of the posterior pharyngeal wall or be fixed to the cervical spine
Larynx: There must by either direct extension into surrounding muscle or skin or greater than 3 cm of sub-glottic extension
Oral cavity: The lesion must be so extensive that a functional reconstruction is not possible.
Base of Tongue: The tumor must extend into the roof of tongue, or the patient must refuse a recommended total glossectomy
Tonsil: The tumor must extend into the pterygoid region as manifested by clinical trismus or demonstrated across the midline of the pharyngeal wall or directly into soft tissue of the neck
Patients with neck lymph node metastases fixed to the carotid artery, the mastoid, the base of the skull, or the cervical spine are considered un-resectable
Medical unsuitability for resection is not sufficient for patient eligibility
Patient's refusal for surgery except in case of total glossectomy is not considered a reason for unresectibility
Patients must have received no prior treatment for head and neck cancer
ECOG Performance status 0-1

Adequate organ function (All labs should be obtained within 14 days prior to start of study drug treatment)

leukocytes > 3,000/mcL
absolute neutrophil count > 1,500/mcL
platelets > 100,000/mcL
total Bilirubin within normal institutional limits
AST (SGOT)/ALT(SGPT) < 2.5 X institutional upper limit of normal
creatinine within normal institutional limits or creatinine clearance > 60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal
Ability to give informed consent and willingness to adhere to study protocol
Subjects of reproductive potential must agree to follow accepted birth control methods during treatment and for 12 months after completion of treatment. Female subject is either post-menopausal or surgically sterilized or willing to use an acceptable method of birth control (i.e., a hormonal contraceptive, intra-uterine device, diaphragm with birth control (i.e., a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence) for the duration of the study

Exclusion Criteria:

Patient who have had prior treatment for head and neck cancer
Prior history of radiation to head and neck area
Known malignancy other than the current cancer
Uncontrolled intercurrent illness including but not limited to ongoing active infection, history of cardiac disease, e.g. uncontrolled hypertension, unstable angina, congestive heart failure, myocardial infarction within last six months or ventricular arrhythmias requiring medication, psychiatric illness that would impair patients ability to comply with study requirements
Pregnant or lactating women (any women becoming pregnant during the study will be withdrawn from the study)
Patient with documented or symptoms of peripheral neuropathy
History of allergic reaction to compounds similar to the ones used in this study
Any condition that would hamper ability to give informed consent or ability to comply with study protocol
HIV patients on anti-retroviral therapy are in-eligible to participate in this study because of potential interaction with the study drugs and increase susceptibility for infections during course of marrow suppressive chemotherapy and radiotherapy