A Pharmacogenetic and Pharmacodynamic Study of Erlotinib (OSI-774) Toxicity in Patients With Advanced Solid Tumors

Inclusion Criteria:

- Patients must have histologically or cytologically confirmed metastatic or
unresectable non-small cell lung cancer, squamous cell carcinoma of the head and
neck, or ovarian cancer

- Eligible patients must have been off previous anticancer therapy including
chemotherapy, radiotherapy, biological therapy, or other investigational therapy for
at least 4 weeks before study entry (6 weeks if prior therapy included nitrosoureas
or mitomycin C)

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

- Life expectancy of greater than 12 weeks

- Leukocytes >= 3,000/ul

- Absolute neutrophil count >= 1,500/ul

- Platelets >= 100,000/ul

- Total bilirubin within normal institutional limits

- Creatinine within normal institutional limits OR creatinine clearance > 60
mL/min/1.73 m^2 for patients with creatinine levels above institutional normal

- Patients must have measurable or assessable disease

- The effects of OSI-774 on the developing human fetus are unknown; for this reason
women of childbearing potential and men must agree to use adequate contraception
(hormonal or barrier method of birth control; abstinence) prior to study entry and
for the duration of study participation; should a woman become pregnant or suspect
she is pregnant while participating in this study, she should inform her treating
physician immediately

- Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

- Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for
nitrosoureas or mitomycin C) prior to entering the study or those who have not
recovered from adverse events due to agents administered more than 4 weeks earlier;
patients with prior treatment with small molecule inhibitors of EGFR, including
erlotinib and gefitinib, are not eligible for this study

- Patients may not be receiving any other investigational agents

- Patients with uncontrolled brain metastasis; patients with brain metastases must have
stable neurologic status following local therapy (surgery or radiation) for at least
4 weeks, and must be without neurologic dysfunction that would confound the
evaluation of neurologic and other adverse events

- History of allergic reactions attributed to compounds of similar chemical or biologic
composition to OSI-774

- 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

- Pregnant women are excluded from this study because OSI-774 is an agent with the
potential for teratogenic or abortifacient effects; because there is an unknown but
potential risk for adverse events in nursing infants secondary to treatment of the
mother with OSI-774, breastfeeding should be discontinued if the mother is treated
with either agent

- HIV-positive patients receiving combination anti-retroviral therapy are excluded from
the study because of possible pharmacokinetic interactions with OSI-774 or other
agents administered during the study; appropriate studies will be undertaken in
patients receiving combination anti-retroviral therapy when indicated

- Patients with significant ophthalmologic abnormalities, including: severe dry eye
syndrome, kerato-conjunctivitis sicca, Sjogren's syndrome, severe exposure
keratopathy, disorders that might increase the risk for epithelium-related
complications (e.g. bullous keratopathy, aniridia, severe chemical burns,
neutrophilic keratitis); patients with mild forms of any of the above, an
asymptomatic history, or a normal ophthalmologic examination may be considered for
inclusion at the discretion of the investigator; an ophthalmologic exam is not needed
prior to this study unless clinically indicated; patients with treatable conditions
(e.g. infectious keratitis/conjunctivitis, allergic conjunctivitis) may be
reevaluated for study eligibility after treatment or resolution of the condition; use
of contact lenses during the course of this trial may increase the risk of corneal
complications and will be strongly discouraged

- Serious, non-healing wound ulcer, or bone fracture

- Major surgical procedure, open biopsy or significant traumatic injury within 14 days
prior to Day 1; following such procedures or injuries, wound healing should be
evident prior to initiation of therapy