Docetaxel, Cisplatin, and Fluorouracil Followed By Cetuximab and Radiation Therapy in Treating Patients With Locally Advanced Head and Neck Cancer
Condition: Head and Neck Cancer
MeSH terms: Head and Neck Neoplasms
Intervention: cetuximab; cisplatin; docetaxel; fluorouracil; computed tomography; positron emission tomography; quality-of-life assessment; 3-dimensional conformal radiation therapy; intensity-modulated radiation therapy
Intervention MeSH terms: Docetaxel; Fluorouracil; Cetuximab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: All
Minimum age: 18 Years
Maximum age: 120 Years
Healthy volunteers: No
Keywords: stage III squamous cell carcinoma of the oropharynx; stage IV squamous cell carcinoma of the oropharynx; stage III squamous cell carcinoma of the hypopharynx; stage IV squamous cell carcinoma of the hypopharynx; stage III squamous cell carcinoma of the larynx; stage III verrucous carcinoma of the larynx; stage IV squamous cell carcinoma of the larynx; stage IV verrucous carcinoma of the larynx

Summary:

      RATIONALE: Drugs used in chemotherapy, such as docetaxel, cisplatin, and fluorouracil, work
      in different ways to stop the growth of tumor cells, either by killing the cells or by
      stopping them from dividing. Monoclonal antibodies, such as cetuximab, can block tumor growth
      in different ways. Some block the ability of tumor cells to grow and spread. Others find
      tumor cells and help kill them or carry tumor-killing substances to them. Radiation therapy
      uses high-energy x-rays to kill tumor cells. Giving combination chemotherapy together with
      cetuximab and radiation therapy may kill more tumor cells.

      PURPOSE: This phase II trial is studying how well giving docetaxel, cisplatin, and
      fluorouracil together with cetuximab and radiation therapy works in treating patients with
      locally advanced head and neck cancer.
    

Eligibility criteria:

        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