Docetaxel/Cisplatin/5-Fluorouracil (TPF) Human Papillomavirus (HPV) Squamous Cell Carcinoma Study
Condition: Squamous Cell Carcinoma of the Head and Neck; Human Papilloma Virus
MeSH terms: Carcinoma; Carcinoma, Squamous Cell; Squamous Cell Carcinoma of Head and Neck; Papilloma
Intervention: docetaxel; cisplatin; 5-FU; IMRT; cetuximab; carboplatin
Intervention description: Given intravenously on day 1 of each cycle
Intervention MeSH terms: Carboplatin; Docetaxel; Fluorouracil; Cetuximab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 7.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: SSCHN; HPV; IMRT

Summary:

      In this research study, the investigators are studying whether a reduced dose of radiation
      when given with standard doses of chemotherapy can reduce side effects without compromising
      control of the cancer. An approved treatment for squamous cell carcinoma of the head and neck
      is initial chemotherapy followed by radiation and chemotherapy together. This treatment is
      effective but has many immediate and long-term side effects. People who have squamous cell
      carcinoma of the head and neck (SSCHN) that is related to an infection by the human
      papillomavirus (HPV) have been shown to have a high response to this treatment along with a
      high cure rate. The investigators think that by reducing the intensity of this treatment,
      they may be able to reduce immediate and long-term side effects which may lead to long term
      improvements in quality of life and function.
    

Eligibility criteria:

        Inclusion Criteria

          -  Histologically or cytologically confirmed squamous cell carcinoma of the oropharynx or
             unknown primary that is HPV 16 positive as determined by ISH and p16 positive as
             determined by IHC.

          -  Stage 3 or 4 disease without evidence of distant metastases

          -  At least one evaluable or uni- or bi-dimensionally measurable lesion by RECIST 1.1
             criteria

          -  18 years of age or older

          -  No previous surgery, radiation therapy or chemotherapy for SSCHN is allowed at time of
             study entry

          -  ECOG Performance Status of 0 or 1

          -  No active alcohol addiction

          -  Adequate bone marrow, hepatic and renal function as defined in the protocol

          -  Women of child-bearing potential must have a negative pregnancy test within 7 days of
             starting treatment

        Exclusion Criteria

          -  Pregnant or breast feeding women or women and men of childbearing potential not
             willing to use adequate contraception while on treatment and for at least 3 months
             after

          -  Previous or current malignancies at other sites

          -  Symptomatic peripheral neuropathy of grade 2 or greater

          -  Symptomatic altered hearing greater than grade 2

          -  Other serious illnesses or medical conditions

          -  Patients that have experienced an involuntary weight loss of more than 25% of their
             body weight in the 2 months preceding study entry

          -  Concurrent treatment with any other anticancer therapy

          -  Participation in an investigational trial within 30 days of study entry