Dasatinib in Treating Patients With Recurrent or Metastatic Head and Neck Cancer
Condition: Metastatic Squamous Neck Cancer With Occult Primary Squamous Cell Carcinoma; Recurrent Metastatic Squamous Neck Cancer With Occult Primary; Recurrent Salivary Gland Cancer; Recurrent Squamous Cell Carcinoma of the Hypopharynx; Recurrent Squamous Cell Carcinoma of the Larynx; Recurrent Squamous Cell Carcinoma of the Lip and Oral Cavity; Recurrent Squamous Cell Carcinoma of the Nasopharynx; Recurrent Squamous Cell Carcinoma of the Oropharynx; Recurrent Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity; Recurrent Verrucous Carcinoma of the Larynx; Recurrent Verrucous Carcinoma of the Oral Cavity; Salivary Gland Squamous Cell Carcinoma; Stage IV Squamous Cell Carcinoma of the Hypopharynx; Stage IV Squamous Cell Carcinoma of the Nasopharynx; Stage IVA Salivary Gland Cancer; Stage IVA Squamous Cell Carcinoma of the Larynx; Stage IVA Squamous Cell Carcinoma of the Lip and Oral Cavity; Stage IVA Squamous Cell Carcinoma of the Oropharynx; Stage IVA Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity; Stage IVA Verrucous Carcinoma of the Larynx; Stage IVA Verrucous Carcinoma of the Oral Cavity; Stage IVB Salivary Gland Cancer; Stage IVB Squamous Cell Carcinoma of the Larynx; Stage IVB Squamous Cell Carcinoma of the Lip and Oral Cavity; Stage IVB Squamous Cell Carcinoma of the Oropharynx; Stage IVB Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity; Stage IVB Verrucous Carcinoma of the Larynx; Stage IVB Verrucous Carcinoma of the Oral Cavity; Stage IVC Salivary Gland Cancer; Stage IVC Squamous Cell Carcinoma of the Larynx; Stage IVC Squamous Cell Carcinoma of the Lip and Oral Cavity; Stage IVC Squamous Cell Carcinoma of the Oropharynx; Stage IVC Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity; Stage IVC Verrucous Carcinoma of the Larynx; Stage IVC Verrucous Carcinoma of the Oral Cavity; Tongue Cancer
MeSH terms: Carcinoma; Carcinoma, Squamous Cell; Head and Neck Neoplasms; Laryngeal Neoplasms; Oropharyngeal Neoplasms; Carcinoma, Verrucous; Squamous Cell Carcinoma of Head and Neck; Salivary Gland Neoplasms; Nasopharyngeal Carcinoma; Paranasal Sinus Neoplasms; Neoplasms, Unknown Primary; Tongue Neoplasms; Laryngeal Diseases; Recurrence
Intervention: dasatinib; pharmacological study; laboratory biomarker analysis
Intervention description: Given PO or via PEG tube; Correlative studies; Correlative studies
Intervention MeSH terms: Dasatinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 15.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This phase II trial studies how well dasatinib works in treating patients with head and neck
      cancer that has come back or spread to other areas of the body. Dasatinib may stop the growth
      of tumor cells by blocking some of the enzymes needed for cell growth.
    

Eligibility criteria:

        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 =< 1 prior chemotherapeutic regimen for recurrent or metastatic
             disease

          -  Eastern Cooperative Oncology Group (ECOG) performance status 0-1

          -  Leukocytes >= 3,000/mcL

          -  Absolute neutrophil count >= 1,500/mcL

          -  Platelets >= 100,000/mcL

          -  Hemoglobin (Hgb) >= 9.0 g/dL

          -  Total bilirubin =< 1.5 X upper limit of normal

          -  Albumin >= 2.5 g/dL

          -  Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) =< 1.5 X upper
             limit of normal

          -  Creatinine =< 3 mg/dl

          -  Paraffin embedded tumor tissue that is appropriate for immunohistochemistry (IHC) and
             fluorescent in situ hybridization (FISH) analysis must be available or patient must be
             amenable to biopsy to obtain tissue for the study

          -  Ability to understand and the willingness to sign a written informed consent document

          -  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,
             intrauterine device [IUD]) or sexual abstinence while in the study and for two months
             following completion of therapy

          -  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

          -  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