Dasatinib in Treating Patients With Recurrent or Metastatic Head and Neck Cancer

Inclusion Criteria

• Patient has histologically proven squamous cell carcinoma of the head and neck that is recurrent after surgery and/or radiation therapy or chemoradiation therapy or is metastatic and disease must be measurable by RECIST criteria
• Patients must have measurable disease as defined by RECIST criteria
• Patients have received = = 3,000/mcL
• Absolute neutrophil count >= 1,500/mcL
• Platelets >= 100,000/mcL
• Hemoglobin (Hgb) >= 9.0 g/dL
• Total bilirubin = = 2.5 g/dL
• Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) = 4 weeks beyond cranial irradiation or must be felt not to require it at that time
• The patient's O2 saturation must be >= 92% on room air

Exclusion Criteria

• Chemotherapy or palliative radiotherapy for recurrent and/or metastatic disease within 3 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or failure to recover to at least grade 1 from adverse events due to agents administered more than 4 weeks earlier; concomitant chemoradiation therapy within 6 weeks prior to entering the study or failure to recover to at least grade 1 from adverse events due to agents administered more than 4 weeks earlier
• Other anti-neoplastic agents, i.e., cytotoxic chemotherapy, immunotherapy, radiotherapy or investigational therapy, used to treat the primary disease will not be allowed during the study; local radiation (excluding radiotherapy to the target lesion) for supportive reasons involving a small radiation field may be allowed
• Patient has a history of uncontrolled or severe medical disease which could compromise participation in the study such as uncontrolled diabetes (fasting blood glucose > 200 mg/dl), uncontrolled hypertension (systolic blood pressure [BP] > 160 or diastolic BP > 100 mmHg), severe infection (bacterial infection requiring intravenous [IV] antibiotics or human immunodeficiency virus [HIV]), angina at rest, congestive heart failure New York Heart Association (NYHA) class III or IV, ventricular arrhythmias requiring therapy, myocardial infarction within 6 months, > grade 2 neuropathy
• Patients may not be receiving any other investigational agents
• Patients who require concurrent treatment with any medications or substances that are potent inhibitors or inducers of cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) are ineligible; efforts should be made to switch patients with gliomas or brain metastases who are taking enzyme-inducing anticonvulsant agents to other medications
• Echocardiogram less than institutional normal measured by echocardiogram for subjects with history of congestive heart failure, symptoms of congestive heart failure, clinical evidence suggesting impaired cardiac function
• Patients may not have any clinically significant cardiovascular disease including the following:
• Myocardial infarction or ventricular tachyarrhythmia within 6 months
• Prolonged correct QT interval (QTc) > 480 msec (Fridericia correction)
• Major conduction abnormality (unless a cardiac pacemaker is present)
• Pregnant women and women who are currently breast-feeding may not participate in this study; all women of childbearing potential must have a negative pregnancy test within 72 hours prior to enrolling in the study; postmenopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential
• Patients having pleural effusion