| Exclusion Criteria: | 1) Patients who present with T1-2N1 disease in which node positivity is based on the presence of retropharyngeal lymph nodes;
2) Prior invasive malignancy (except non-melanomatous skin cancer) unless disease-free for a minimum of 3 years (e.g., carcinoma in situ of the breast, oral cavity, or cervix are all permissible);
3) Prior systemic chemotherapy for the study cancer; note that prior chemotherapy for a different cancer is permitted;
4) Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields;
5) Prior treatment with bevacizumab or other agents specifically targeting VEGF;
6) Head and neck surgery of the primary tumor or lymph nodes prior to registration, with the exception of incisional or excisional biopsies; Note: See Section 4.1.1 regarding timeframe restrictions for biopsies.
7) Patients with gross hemoptysis or hematemesis (defined as bright red blood of 1 teaspoon or more per coughing episode) within 4 weeks prior to registration; patients with incidental blood mixed with phlegm are not excluded.
8) Patients receiving other experimental therapeutic cancer treatment;
9) Blood pressure at baseline > 150/100 mmHg;
10) Patients with hearing loss felt to be primarily sensorineural in nature, requiring a hearing aid or intervention (i.e., interfering in a clinically significant way with activities of daily living); conductive hearing loss from tumor-related otitis media is allowed.
11) Peripheral neuropathy CTCAE, v. 3.0 >/= grade 2;
12) Severe, active co-morbidity, defined as follows: Major medical or psychiatric illness, which in the investigators' opinion would interfere with the completion of therapy and follow up or with full understanding of the risks and potential complications of the therapy; Unstable angina and/or congestive heart failure or peripheral vascular disease requiring hospitalization within the last 12 months, or other cardiac compromise that in the judgment of the investigator will preclude the safe administration of a study drug;
13) History of arterial thromboembolic events, transient ischemic attack (TIA), cerebral vascular accident (CVA), or transmural myocardial infarction (MI) ; History of ongoing bleeding diathesis, hemorrhagic disorder, or coagulopathy within the last 6 months; Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days prior to registration; History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the last 6 months prior to registration;
14) Esophageal varices, non-healing ulcer, non-healing wound, or bone fracture within the last 6 months prior to registration; Active, untreated infection and/or acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration; Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects; History of significant weight loss (> 15% from baseline);
15) Acquired Immune Deficiency Syndrome (AIDS) based upon current CDC definition; note, however, that HIV testing is not required for entry into this protocol. The need to exclude patients with AIDS from this protocol is necessary because the treatments involved in this protocol may be significantly immunosuppressive. Protocol-specific requirements also may exclude immuno-compromised patients.
16) Patients currently taking warfarin, heparin, daily treatment with aspirin (> 325 mg/day), or nonsteroidal anti-inflammatory medications known to inhibit platelet function; treatment with dipyramidole (Persantine®), ticlopidine (Ticlid®), clopidogrel (Plavix®), or cilostazol (Pletal®); Note: To be eligible for the study, patients must discontinue these medications >/= 10 days prior to study entry and must have an INR and an aPTT </= 1.5 X UNL within 2 weeks prior to registration;
17) Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception; this exclusion is necessary because the treatment involved in this study may be significantly teratogenic.
18) Prior allergic reaction to the study drug(s) involved in this protocol. |