Study of Chemotherapy With Cisplatin/Carboplatin, and Docetaxel With or Without Erlotinib in Patients With Head and Neck Squamous Cell Carcinomas Amenable for Surgical Resection

Prior treatment

• Prior chemotherapy or biologic therapy for the same HNSCC. Prior chemotherapy or biologic therapy for a different previous HNSCC is allowed
• Other active solid malignancies within 2 years prior to randomization, except for basal cell or squamous cell skin cancer or in situ cervical or breast cancer or superficial melanoma.
• Any concurrent anticancer therapy, excluding hormonal therapy for prostate or breast cancer.

Other illness

• History of poorly controlled gastrointestinal disorders that could affect the absorption of the study drug (e.g., Crohn's disease, ulcerative colitis). Patients requiring feeding tubes are permitted
• Serious underlying medical condition which would impair the ability of the patient to receive protocol treatment, in the opinion of the treating physician.
• History of allergic reactions to compounds of similar chemical composition to the study drugs (docetaxel, cisplatin, carboplatin, erlotinib or their excipients), or other drugs formulated with polysorbate 80.

Other

• Histology other than squamous cell carcinoma.
• Primary sites other than oral cavity.
• Women who are pregnant or breast-feeding and women or men not practicing effective birth control.

• Suspected or histologically/citologically confirmed HNSCC of the oral cavity, stage III, IVA or IVB (according to the AJCC 7th edition). Patients with a suspected lesion may be enrolled and a baseline biopsy will be obtained as part of the study. If squamous cell histology is not confirmed, patients will be discontinued from the study.
• Patients must have surgically resectable disease, in the opinion of the treating physician
• Age ≥ 18 years.
• ECOG PS ≤ 2 (Appendix C)
• Adequate bone marrow, hepatic and renal function defined by: 6. ANC ≥ 1.5 x 109/L;
  • 7\. Platelet count ≥ 100 x 109/L;
  • 8\. ALT (SGPT) ≤ 1.5 x upper limit of normal (ULN);
  • 9\. Total bilirubin ≤ ULN (patient's with Gilbert's syndrome are eligible, even if total bilirubin is \> ULN);
  • 10\. Alkaline phosphatase ≤ 2.5 x ULN;
  • 11\. Serum creatinine ≤ 1.5 x ULN.
  • 12\. Patients with reproductive potential (e.g., females menopausal for less than 1 year and not surgically sterilized) must practice effective contraceptive measures for the duration of study drug therapy and for at least 30 days after completion of study drug therapy. Female patients of childbearing potential must provide a negative pregnancy test (serum or urine) ≤ 14 days prior to treatment initiation.
  • 13\. Written informed consent to participate in the study according to the investigational review board (IRB).