Dasatinib in Patients With Head and Neck Squamous Cell Carcinoma

Inclusion Criteria:

1. Patient has histologically proven squamous cell carcinoma of the head and neck that is recurrent after surgery and/or radiation therapy or chemoradiation therapy that was completed more than 6 months prior to study entry or is metastatic. and disease must be measurable by Response Evaluation Criteria In Solid Tumors (RECIST) criteria.
2. Patients must have measureable disease as defined by RECIST criteria.
3. Patients have received </= 1 prior chemotherapeutic regimen for recurrent or metastatic disease
4. Age >/= 18 years. Because dasatinib is currently being studied in a phase 1 pediatric trial (ADVL0516), eligibility for the current trial is restricted to adults.
5. Eastern Cooperative Oncology Group (ECOG) performance status 0-1
6. Patients must have normal organ and marrow function as defined below: leukocytes >/= 3,000/mcL, absolute neutrophil count >/= 1,500/mcL, platelets >/= 100,000/mcL, Hgb >/= 9.0 g/dL, total bilirubin </= 1.5 * institutional upper limit of normal, albumin >/= 2.5 g/dL, AST(SGOT)/ALT(SGPT) </= 1.5 * institutional upper limit of normal, creatinine </= 3 mg/dl
7. Paraffin embedded tumor tissue that is appropriate for IHC and FISH analysis must be available or patient must be amenable to biopsy to obtain tissue for the study.
8. Ability to understand and the willingness to sign a written informed consent document.
9. Patient must not be pregnant or breastfeeding. All sexually active females of child-bearing potential and all sexually active males with sexual partners of child-bearing potential should practice contraception (e.g. barrier, hormonal, IUD) or sexual abstinence while in the study and for two months following completion of therapy.
10. Brain metastases permitted provided the patient does not require anticonvulsants or corticosteroids, or has been off them at least 7 days. Patients with brain metastases must be either > 4 weeks beyond cranial irradiation or must be felt not to require it at that time.
11. The patient's O2 saturation must be >/= 92% on room air.

Exclusion Criteria:

1. 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.
2. 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.
3. 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 BP>160 or diastolic BP>100 mm Hg), severe infection (bacterial infection requiring antibiotics or HIV), angina at rest, congestive heart failure New York Hearth Association (NYHA) class III or IV, ventricular arrhythmias requiring therapy, myocardial infarction within 6 months, (stated below), >grade 2 neuropathy.
4. Patients may not be receiving any other investigational agents.
5. Patients who require concurrent treatment with any medications or substances that are potent inhibitors or inducers of CYP3A4 are ineligible.
6. 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.
7. Use of antithrombotic and/or anti-platelet agents (e.g., warfarin, heparin, low molecular weight heparin, and/or ibuprofen). Exception: Patients taking low dose aspirin.
8. Patients may not have any clinically significant cardiovascular disease including the following: myocardial infarction or ventricular tachyarrhythmia within 6 months, prolonged QTc>480 msec (Fridericia correction), major conduction abnormality (unless a cardiac pacemaker is present).
9. Pregnant women & women who are currently breast-feeding may not participate in this study. All women of childbearing potential must have a negative pregnancy test w/in 24 hours prior to enrolling in the study. All sexually active females of child-bearing potential & all sexually active males with sexual partners of child-bearing potential should practice contraception (e.g. barrier, hormonal, IUD) or sexual abstinence while in the study & for two months following completion of therapy. Postmenopausal women must be amenorrheic for at least 12 mths to be considered of non-childbearing potential.
10. Patients having pleural effusion