Bevacizumab, Fluorouracil, and Hydroxyurea Plus Radiation Therapy in Treating Patients With Advanced Head and Neck Cancer
Metastatic Squamous Neck Cancer With Occult Primary Squamous Cell Carcinoma, Recurrent Adenoid Cystic Carcinoma of the Oral Cavity, Recurrent Basal Cell Carcinoma of the Lip
About this trial
This is an interventional treatment trial for Metastatic Squamous Neck Cancer With Occult Primary Squamous Cell Carcinoma
Eligibility Criteria
Inclusion Criteria: Histologically or cytologically confirmed advanced head and neck cancer Requiring regional palliative radiotherapy Not amenable to standard therapy Previously untreated disease allowed only if prognosis is poor (i.e., estimated 2-year survival of less than 10% if treated with standard therapy alone) No obvious tumor involvement of major vessels on CT scan No known brain metastases Performance status - ECOG 0-2 Performance status - Karnofsky 60-100% More than 12 weeks WBC at least 3,000/mm^3 Absolute neutrophil count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 No history of bleeding diathesis Bilirubin normal AST/ALT no greater than 2.5 times upper limit of normal Creatinine normal Urine protein no greater than trace Urine protein less than 0.5 g/24 hours No significant renal impairment No symptomatic congestive heart failure No cardiac arrhythmia No deep venous thrombosis No uncontrolled hypertension No clinically significant peripheral artery disease No arterial thromboembolic event within the past 6 months, including any of the following: Transient ischemic attack Cerebrovascular accident Unstable angina Myocardial infarction No hemoptysis of at least 1 tablespoon No history of allergic reactions attributed to compounds of similar chemical or biologic composition to bevacizumab or other agents used in this study No non-healing wounds within the past 4 weeks No significant ongoing or active infection No other uncontrolled illness No other severe complicating medical illness that would preclude study participation No psychiatric illness or social situation that would preclude study compliance Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No prior fluorouracil and hydroxyurea with radiotherapy At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered See Disease Characteristics See Chemotherapy At least 4 months since prior radiotherapy and recovered At least 4 weeks since prior major surgery No prior or concurrent chronic use of aspirin or other nonsteroidal anti-inflammatory agents No other concurrent investigational agents No concurrent anticoagulation therapy No concurrent combination antiretroviral therapy for HIV-positive patients No other concurrent anticancer agents
Sites / Locations
- University of Chicago Comprehensive Cancer Center
Arms of the Study
Arm 1
Experimental
Treatment (hydroxyurea, fluorouracil, bevacizumab, radiation)
Patients receive oral hydroxyurea every 12 hours on days 1-6, fluorouracil IV continuously on days 1-5, and bevacizumab IV over 90 minutes on day 1. Patients also undergo radiotherapy once daily on days 1-5. Patients receive G-CSF subcutaneously on days 6-12. Treatment repeats every 2 weeks for up to 7 courses in the absence of disease progression or unacceptable toxicity.