A Clinical Trial to Validate Molecular Targets of Vorinostat in Patients With Aerodigestive Tract Cancer

Inclusion Criteria:

- All patients must have pathological confirmation of non small cell carcinoma of the
aerodigestive tract (lung, esophagus, head and neck cancer).

- Patients must have resectable clinical stage I - III non small cell lung, clinical
stage I-III esophageal cancer, or stage I-IV A head and neck cancer.

- Age >18 years.

- Adequate hepatic and renal function documented prior to study entry to include:
hepatic transaminases (AST or ALT) ≤ 2.0 times the upper limits of normal, total
bilirubin ≤ 1.5 times the upper limits of normal, serum creatinine ≤ 1.5 times the
upper limit of normal or estimated creatinine clearance ≥ 60 mL/min.

- All patients must be medical candidates for surgical resection of their non-small cell
lung cancer.

- All patients must give informed consent indicating they are aware of the
investigational nature of this treatment.

Exclusion Criteria:

- Patients may not have received radiation therapy for their aerodigestive tract cancer.

- Patients may not have received chemotherapy for their aerodigestive tract cancer.

- Women must be surgically sterilized or post-menopausal or women of childbearing
potential must be using an adequate method of contraception. Women of childbearing
potential must be using at least one of the following: oral, implanted, injectable
contraceptive hormones, or mechanical products such as an intrauterine device or
barrier methods (diaphragm, condoms, spermicides) to prevent pregnancy or practicing
abstinence or have a partner that is sterile (e.g., vasectomy). Women of childbearing
potential must have a negative serum or urine pregnancy test within 72 hours prior to
start of study therapy.

- Women who are pregnant or breast-feeding will be excluded.

- Male patients with partners of childbearing potential not using an adequate method of
birth control as described in the previous paragraph will be excluded.

- Patients with gastrointestinal abnormalities including: inability to take oral
medication, requirement for intravenous alimentation, or prior surgical procedures
affecting absorption will be excluded.

- A serious uncontrolled medical disorder or active infection which would impair their
ability to receive study treatment will be excluded. Significant cardiac disease,
including uncontrolled high blood pressure, unstable angina, congestive heart failure,
myocardial infarction within the previous 3 months or serious cardiac arrythmias will
be excluded. Dementia or significantly altered mental status that would prohibit the
understanding or rendering of informed consent and compliance with the requirements of
this protocol will be excluded.

- Patients with active HIV, Hepatitis C virus (HCV) or Hepatitis B virus (HBV)
infection.

- No prior treatment with histone deacetylase (HDAC) inhibitors. Valproic acid is
acceptable if not used as anticancer therapy and a 30-day wash-out period is allowed.

- Exposure to other investigational agents within 30 days of study inclusion

- Patients with a "currently active" second malignancy, other than nonmelanoma skin
cancer and carcinoma in situ of the cervix, should not be enrolled. Patients would not
be considered to have a "currently active" malignancy if they have completed therapy
for a prior malignancy, are disease free from prior malignancies for >5 years or are
considered by their physician to be at less than 30% risk of relapse.

- Patients with history of pulmonary embolism who are not receiving anticoagulation,
will be excluded.