Chemotherapy Followed by Surgery, 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: cisplatin; docetaxel; fluorouracil; gemcitabine hydrochloride; leucovorin calcium; gene expression analysis; protein expression analysis; laboratory biomarker analysis; adjuvant therapy; biopsy; conventional surgery; neoadjuvant therapy; quality-of-life assessment; radiation therapy
Intervention MeSH terms: Leucovorin; Gemcitabine; Docetaxel; Fluorouracil; Calcium; Levoleucovorin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 31.0
Sex: All
Minimum age: 0 Years
Maximum age: 120 Years
Healthy volunteers: No
Keywords: stage III squamous cell carcinoma of the larynx; stage IV squamous cell carcinoma of the larynx; stage III squamous cell carcinoma of the hypopharynx; stage III squamous cell carcinoma of the oropharynx; stage IV squamous cell carcinoma of the hypopharynx; stage IV squamous cell carcinoma of the oropharynx; stage III squamous cell carcinoma of the lip and oral cavity; stage IV squamous cell carcinoma of the lip and oral cavity; stage II squamous cell carcinoma of the larynx; stage II squamous cell carcinoma of the hypopharynx; stage II squamous cell carcinoma of the oropharynx

Summary:

      RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor
      cells, either by killing the cells or by stopping them from dividing. Giving combination
      chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue
      that needs to be removed. Radiation therapy uses high-energy x-rays to kill tumor cells.
      Drugs such as gemcitabine and cisplatin may make tumor cells more sensitive to radiation
      therapy. Giving combination chemotherapy before surgery or radiation therapy may kill more
      tumor cells.

      PURPOSE: This phase II trial is studying how well giving chemotherapy followed by surgery,
      chemotherapy, and radiation therapy works in treating patients with locally advanced head and
      neck cancer.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically confirmed squamous cell carcinoma of the head and neck, including any
             of the following subtypes:

               -  Oral cavity

               -  Oropharynx

               -  Hypopharynx

               -  Larynx

          -  Stage III or IV disease

               -  Stage II carcinoma of the larynx, hypopharynx, or base of tongue allowed

          -  Measurable disease

          -  Resectable disease, defined as tumors that are potentially curable by surgery and
             radiotherapy

        PATIENT CHARACTERISTICS:

          -  Karnofsky performance status ≥ 60%

          -  ANC ≥ 1,500/μL

          -  Platelet count ≥ 100,000/μL

          -  Creatinine ≤ 1.5 mg/dL OR creatinine clearance > 60 mL/min

          -  Bilirubin ≤ 1.5 mg/dL

          -  Transaminases and alkaline phosphatase meeting 1 of the following criteria:

               -  ALT or AST ≤ 2.5 times upper limit of normal (ULN) AND alkaline phosphatase
                  normal

               -  Alkaline phosphatase ≤ 4 times ULN AND ALT and AST normal

               -  ALT or AST < 1.5 times ULN AND alkaline phosphatase < 2.5 times ULN

          -  Free of serious infection

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception

          -  No prior malignancy allowed for purposes of determining disease-free or overall
             survival except adequately treated basal cell or squamous cell skin cancer, in situ
             cervical cancer, or other cancer for which the patient has been disease free for 5
             years

          -  No unstable angina, history of congestive heart failure, or acute myocardial
             infarction within the past 6 months

          -  No current symptomatic, neurosensory or neuromotor toxicity ≥ grade 2

          -  No other significant medical or psychiatric condition incompatible with the protocol

        PRIOR CONCURRENT THERAPY:

          -  No prior chemotherapy or radiotherapy for head and neck cancer