Phase II Trial of Nelfinavir With Concurrent Chemoradiotherapy in Squamous Cell Carcinoma of the Head and Neck

Exclusion Criteria

• •Prior radiation therapy to the head and neck
• •Prior chemotherapy within the past 5 years
• •Previous therapy with a human immunodeficiency virus (HIV) protease inhibitor
• •Pregnant or lactating patients.
• •Patients with known HIV disease. These patients have a high probability of treatment with anti-retroviral therapy which may interact with the nelfinavir.
• •Absolute Neutrophil Count ≤ 1500 per mm3
• •Platelet count ≤ 100,000 per mm3
• •Serum creatinine \> 1.5 times the upper limit of normal
• •Serum AST or ALT \> 2 times the upper limit of normal
• •Serum bilirubin \> 1.2 mg/dl
• •Weight loss of \> 10% over the past 6 months which is due to tumor wasting syndrome
• •Distant metastases
• •Patients receiving the following drugs that are contraindicated with NFV will be excluded: Antiarrhythmics:amiodarone, quinidine, Antimycobacterial: rifampin, Ergot Derivatives:dihydroergotamine, ergonovine, ergotamine, methylergonovine, Herbal Products: St.John's wort (hypericum perforatum), HMG-CoA Reductase Inhibitors: lovastatin,simvastatin, Neuroleptic:pimozide, Proton Pump Inhibitors, Sedative/Hypnotics: midazolam, triazolam,
• •Patients receiving the following drugs will be clinically evaluated as to whether dosage/medication can be changed to permit patient on study: Anti-Convulsants: carbamazepine, Phenobarbital, Anti-Convulsant:phenytoin, Anti-Mycobacterial:rifabutin, PDE5 Inhibitors: sildenafil, vardenafil, tadalafil, HMG-CoA: Reductase Inhibitors: atorvastatin, rosuvastatin, Immuno-suppressants: cyclosporine,tacrolimus, sirolimus, Narcotic Analgesic: methadone, Oral Contraceptive:ethinyl estradiol, Macrolide Antibiotic:azithromycin, Inhaled/nasal steroid fluticasone, Antidepressant: trazodone.
• •Women of childbearing potential who have a positive result on screening urine pregnancy test.
• •Subjects with moderate-severe renal disease.
• •History of allergic reactionsattributed to Flagyl (metronidazole), which has a chemical structure similar to FMISO.
• •Uncontrolled intercurrent illness including, but not limited to symptomatic congestive heart failure, unstable angina pectoris, or psychiatric illness/social situations that would limit compliance with study requirements.