Bevacizumab, Docetaxel, and Radiation Therapy in Treating Patients With Stage III or Stage IV Head and Neck Cancer
Head and Neck Cancer
About this trial
This is an interventional treatment trial for Head and Neck Cancer focused on measuring 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
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
Sites / Locations
- Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
- Lake/University Ireland Cancer Center
- Southwest General Health Center
- UHHS Chagrin Highlands Medical Center
- UHHS Westlake Medical Center
- UPMC Cancer Centers
Arms of the Study
Arm 1
Experimental
bevacizumab with docetaxel and radiation therapy