Combination Chemotherapy 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: filgrastim; pegfilgrastim; cisplatin; docetaxel; fluorouracil; conventional surgery; radiation therapy
Intervention description: subcutaneously on Days 5-14, repeating every 3 weeks for 2 courses.; If applicable on day 5, repeating every 3 weeks for 2 courses.; Intravenous over 1 hour on day 1, every 3 weeks for 3 courses.; Intravenous over 1 hour on day 1.; Intravenous continuously on days 1-4.; As appropriate, neck dissection.; 60 Gy 5 days/week x 6 weeks with cisplatin
Intervention MeSH terms: Docetaxel; Fluorouracil; Lenograstim
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 4.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: oral complications of radiation therapy; oral complications of chemotherapy; mucositis; xerostomia; 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 IV squamous cell carcinoma of the larynx; stage III squamous cell carcinoma of the lip and oral cavity; stage IV squamous cell carcinoma of the lip and oral cavity; stage III squamous cell carcinoma of the oropharynx; stage IV squamous cell carcinoma of the oropharynx

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. Radiation therapy uses high-energy x-rays to kill tumor cells.
      Giving combination chemotherapy together with radiation therapy may kill more tumor cells.

      PURPOSE: This phase II trial is studying how well giving combination chemotherapy together
      with radiation therapy works in treating patients with locally advanced head and neck cancer.
      The doctor also wants to find out if patients who receive this treatment need a feeding tube
      1 year after starting treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically confirmed squamous cell carcinoma of the head and neck

               -  Stage IVA or IVB disease

                    -  Stage III disease allowed provided patient may benefit from organ
                       preservation or patient refused surgery

          -  Measurable or evaluable disease

          -  ECOG performance status 0-2

          -  Absolute neutrophil count ≥ 1,500/mm^3

          -  Platelet count ≥ 100,000/mm^3

          -  Creatinine ≤ 1.5 mg/dL OR glomerular filtration rate ≥ 60 mL/min

          -  Bilirubin normal

          -  Alkaline phosphatase (AP) and AST or ALT must be within the following ranges:

               -  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

        Exclusion Criteria:

          -  Salivary gland, sinus, or nasopharyngeal primary disease

          -  Evidence of distant metastatic disease

          -  Pregnant or nursing

          -  Positive pregnancy test (Fertile patients must use effective contraception during
             study treatment and for 3 months after completion of study treatment)

          -  Other malignancy within the past 5 years except for adequately treated basal cell or
             squamous cell skin cancer, in situ cervical cancer, or other malignancy in which stage
             and nature of disease is such that it is unlikely to affect survival for the next 3
             years

          -  Peripheral neuropathy ≥ grade 2

          -  Hearing loss ≥ grade 2

          -  Severe hypersensitivity reaction to docetaxel or other drugs formulated with
             polysorbate 80 and/or cisplatin or other platinum analogs

          -  Poor nutritional status, in the opinion of the investigator

          -  Active infection

          -  Active ischemic heart disease

          -  Myocardial infarction within the past 6 months

          -  Prior radiotherapy above the clavicles

          -  Prior chemotherapy

          -  Prior surgery to the primary tumor except biopsy

          -  Concurrent amifostine or other investigational agents