Phase I Study of Azacitidine in Combination With Cisplatin in Patients With Recurrent or Metastatic Non-small Cell Lung Cancer or Squamous Cell Carcinoma of the Head and Neck

Inclusion Criteria:

- Patients must have histologically proven squamous cell carcinoma of head and neck or
non-small cell lung cancer that is either metastatic or has persisted or recurred
following definitive surgery and/or radiation therapy, and is not amenable to salvage
surgical resection.

- Patients may have received previous chemotherapy and/or biological treatment such as
cetuximab, bevacizumab or erlotinib) for the recurrent or metastatic disease. Prior
treatment must have been completed at least 28 days (42 days for nitrosoureas or
mitomycin C) prior to entering the study and all toxicities must have been resolved.
Patients who have received prior treatment with EGFR inhibitor alone such as
cetuximab or erlotinib are allowed to enter the study at least 14 days after
receiving the last dose of the prior treatment.

- Prior radiation must have been completed at least 28 days before entry into the study
and all toxicities must have been resolved (no more than 3000 cGy to fields including
substantial marrow).

- Surgery must have been completed at least 28 days 28 days before entry into the study
and all complications/adverse events must have been resolved.

- Age >18 years.

- ECOG performance status <2 (Karnofsky >60%).

- Life expectancy of greater than 3 months.

- Patients must have normal organ and marrow function

- Patients must not be planning to receive any other concurrent therapy (i.e.
radiation, chemotherapy, immunotherapy, biological therapy or gene therapy) while
they are on this study.

- Patients must be able to understand and sign a written informed consent document
approved for this trial.

- Women of childbearing potential must have a negative serum pregnancy test prior to
azacitidine treatment.

Exclusion Criteria:

- Patients with symptomatic brain metastases are excluded from this clinical trial.
Patients with asymptomatic brain metastases are allowed. The patient must be stable
for 2 weeks after radiotherapy; if the patient is on corticosteroids, the dose of
cortico steroids must have been stable for 2 weeks prior to first dose of study
treatment, or be in the process of being tapered.

- History of allergic reactions attributed to compounds of similar chemical or biologic
composition to azacitidine, cisplatin and mannitol or other agents used in study.

- Pregnant or nursing women may not participate in this trial because of the increased
risk of fetal harm including fetal death from the chemotherapeutic agents. Women/men
of reproductive potential may not participate unless they have agreed to use an
effective contraceptive method.

- Uncontrolled intercurrent illness including, but not limited to, ongoing or active
infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
arrhythmia, or psychiatric illness/social situations that would limit compliance with
study requirements.

- Patients known to be HIV-positive are not eligible because of the potential to
confound this study's endpoints.

- No prior malignancy is allowed except for adequately treated basal cell (or squamous
cell) skin cancer, in situ cervical cancer or other cancer for which the patient has
been disease-free for five years.