Bevacizumab, Docetaxel, and Radiation Therapy in Treating Patients With Stage III or Stage IV Head and Neck Cancer
Condition: Head and Neck Cancer
MeSH terms: Head and Neck Neoplasms
Intervention: bevacizumab; docetaxel; conventional surgery; radiation therapy
Intervention description: Bevacizumab IV over 30-90 minutes once every 2 weeks for up to 1 year. Bevacizumab, which stops 8 weeks before surgery, may restart 4 weeks after surgery and continue for 9 months in the absence of disease progression or unacceptable toxicity.; docetaxel IV over 1 hour once a week for 8 weeks; 8-10 weeks after the completion of chemoradiotherapy, patients may undergo neck dissection; radiotherapy once daily, 5 days a week, for 8 weeks
Intervention MeSH terms: Bevacizumab; Docetaxel
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: 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 nasopharynx; stage IV squamous cell carcinoma of the nasopharynx; stage III squamous cell carcinoma of the oropharynx; stage IV squamous cell carcinoma of the oropharynx

Summary:

      RATIONALE: Monoclonal antibodies, such as bevacizumab, 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. Bevacizumab may also stop the
      growth of tumor cells by blocking blood flow to the tumor. Drugs used in chemotherapy, such
      as docetaxel, 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 bevacizumab together with docetaxel and radiation therapy may kill more
      tumor cells.

      PURPOSE: This phase II trial is studying how well giving bevacizumab together with docetaxel
      and radiation therapy works in treating patients with stage III or stage IV head and neck
      cancer.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically or cytologically confirmed squamous cell carcinoma of the head and neck

               -  Stage III or IV disease

                    -  No evidence of distant metastases

               -  No salivary gland or paranasal sinus squamous cell carcinoma

          -  No disease with close proximity to a major vessel

          -  Measurable disease

          -  No known CNS or brain metastases

               -  Patients with intracranial extension without cerebral involvement may be eligible

        PATIENT CHARACTERISTICS:

          -  ECOG performance status 0-1

          -  Life expectancy > 12 weeks

          -  Absolute neutrophil count ≥ 1,500/mm^3

          -  Platelet count ≥ 100,000/mm^3

          -  Hemoglobin ≥ 10 g/dL

          -  Bilirubin normal

          -  AST and ALT ≤ 2 times upper limit of normal

          -  PT normal

          -  Creatinine normal OR

          -  Creatinine clearance ≥ 60 mL/min

          -  Urine protein: creatinine ratio < 1.0

          -  No bleeding diathesis or coagulopathy

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception

          -  No history of allergic reaction attributed to compounds of similar chemical or
             biological composition to study drugs

          -  No pre-existing peripheral neuropathy ≥ grade 2

          -  No ongoing or active infection

          -  No serious non-healing wound, ulcer, or bone fracture

          -  No New York Heart Association class II-IV congestive heart failure

          -  No significant arrhythmias requiring medication

          -  No myocardial infarction within the past 6 months

          -  No stroke within the past 6 months

          -  No symptomatic coronary artery disease

          -  No second- or third-degree heart block or bundle branch block

          -  No unstable angina pectoris

          -  No hypertension (i.e., blood pressure ≥ 150/100 mm Hg)

          -  No other clinically significant heart disease

          -  No significant traumatic injury within the past 4 weeks

          -  No psychiatric illness or social situation that would preclude study compliance

          -  No HIV positivity

          -  No other malignancy within the past 5 years except squamous cell or basal cell skin
             cancer or carcinoma in situ of the cervix

          -  No other uncontrolled illness

          -  No poorly compliant patients

        PRIOR CONCURRENT THERAPY:

          -  No prior chemotherapy or radiotherapy

          -  No prior investigational anticancer agents

          -  More than 4 weeks since prior major surgery

          -  More than 1 week since prior minor surgery, fine-needle aspiration, or core needle
             biopsy

          -  No concurrent major surgery except planned neck dissection

          -  No concurrent routine colony-stimulating factor therapy

          -  No other concurrent investigational agents

          -  No other concurrent anticancer therapy