Radiation Therapy and Docetaxel in Treating Patients With HPV-Related Oropharyngeal Cancer
Condition: Human Papillomavirus Infection; Stage I Oropharyngeal Squamous Cell Carcinoma; Stage II Oropharyngeal Squamous Cell Carcinoma; Stage III Oropharyngeal Squamous Cell Carcinoma; Stage IVA Oropharyngeal Squamous Cell Carcinoma; Stage IVB Oropharyngeal Squamous Cell Carcinoma
MeSH terms: Papillomavirus Infections; Carcinoma; Carcinoma, Squamous Cell; Squamous Cell Carcinoma of Head and Neck
Intervention: Docetaxel; Hyperfractionation; Intensity-Modulated Radiation Therapy; Laboratory Biomarker Analysis; Quality-of-Life Assessment
Intervention description: Given IV; Undergo hyperfractionated IMRT; Undergo hyperfractionated IMRT; Correlative studies; Ancillary studies
Intervention MeSH terms: Docetaxel
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 81.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This phase II trial studies how well radiation therapy and docetaxel work in treating
      patients with human papillomavirus (HPV)-related oropharyngeal cancer. Radiation therapy uses
      high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as docetaxel, work
      in different ways to stop the growth of tumor cells, either by killing the cells, by stopping
      them from dividing, or by stopping them from spreading. Giving radiation therapy with
      docetaxel my kill more tumor cells.
    

Eligibility criteria:

        Inclusion Criteria:

          -  PRE-REGISTRATION

          -  Provide written informed consent

          -  Submission of research blood draw to be stored until after surgical resection of the
             primary tumor and confirmation of human papilloma virus (HPV) positivity (Mayo Clinic
             Rochester patients only)

          -  Patients with oropharynx carcinoma with a smoking history of ˂ 10 pack-year or
             equivalent 10 year history of tobacco product use and no recent history (within last 5
             years) of tobacco use

          -  REGISTRATION

          -  Histological confirmation of HPV+ squamous cell carcinoma of the oropharynx; HPV
             positivity will be defined as positive staining for p16 on immunohistochemistry (IHC)

          -  Gross total surgical resection with curative intent of the primary tumor and at least
             unilateral neck dissection within 7 weeks of registration

          -  Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1

          -  Smoking history < 10 pack years or equivalent 10 year history of tobacco product use

          -  Absence of distant metastases on standard diagnostic work-up =< 10 weeks prior to
             registration; (chest computed tomography [CT], chest x-ray [CXR], positron emission
             tomography [PET]/CT, etc.)

          -  Must have one of the following risk factors:

               -  Lymph node > 3 cm

               -  2 or more positive lymph nodes

               -  Perineural invasion

               -  Lymphovascular space invasion

               -  T3 or microscopic T4a primary disease

               -  Lymph node extracapsular extension

          -  Absolute neutrophil count (ANC) >= 1500/mm^3

          -  Platelet count >= 100,000/mm^3

          -  Hemoglobin >= 9.0 g/dL

          -  Direct bilirubin within upper limit of normal (ULN)

          -  Creatinine =< ULN x 1.5

          -  Negative pregnancy test done =< 7 days prior to registration, for women of
             childbearing potential only

          -  Ability to complete questionnaire(s) by themselves or with assistance

          -  Provide informed written consent

          -  Willingness to return to enrolling institution for follow-up (during the active
             monitoring phase of the study)

        Exclusion Criteria:

          -  Any significant tobacco history within the past five years

          -  Any of the following:

               -  Pregnant women

               -  Nursing women

               -  Men or women of childbearing potential who are unwilling to employ adequate
                  contraception

          -  Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment
             of the investigator, would make the patient inappropriate for entry into this study or
             interfere significantly with the proper assessment of safety and toxicity of the
             prescribed regimens

          -  Immunocompromised patients and patients known to be human immunodeficiency virus (HIV)
             positive

          -  Uncontrolled intercurrent illness including, but not limited to, ongoing or active
             infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
             arrhythmia, or psychiatric illness/social situations that would limit compliance with
             study requirements

          -  Receiving any other investigational agent which would be considered as a treatment for
             the primary neoplasm

          -  Other active malignancy =< 5 years prior to registration; EXCEPTIONS: non-melanotic
             skin cancer or carcinoma-in-situ of the cervix; NOTE: if there is a history or prior
             malignancy, they must not be receiving other specific treatment for their cancer

          -  History of myocardial infarction =< 180 days prior to registration, or congestive
             heart failure requiring use of ongoing maintenance therapy for life-threatening
             ventricular arrhythmias

          -  Prior history of radiation therapy to the affected site

          -  History of connective tissue disorders such as rheumatoid arthritis, lupus, or
             Sjogren's disease

          -  Presence of any of the following risk factors after surgery:

               -  Any positive surgical margin

               -  Adenopathy below the clavicles

          -  Prior systemic chemotherapy for the study cancer; NOTE: prior chemotherapy for a
             different cancer is allowable

          -  History of allergic reaction to docetaxel

          -  Receiving any medications or substances that are strong or moderate inhibitors of
             cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4)

               -  Use of strong or moderate inhibitors is prohibited =< 7 days prior to
                  registration

          -  Receiving any medications or substances that are inducers of CYP3A4

               -  Use of inducers is prohibited =< 12 days prior to registration