Trial Comparing the Use of FLT PET to Standard CT to Assess Treatment Response of Neoadjuvant Docetaxel and Cisplatin in Stage IB-IIIA Resectable NSCLC

Please see the primary and secondary outcomes listed below.

Inclusion Criteria:

- Patients must have histologically or cytologically confirmed clinical stage IB - IIIA
non-small cell lung cancer. Mixed tumors will be categorized by the predominant cell
type unless small cell elements are present in which case the patient is ineligible.

- Patients must be surgically resectable as determined by a thoracic surgeon.

- Patients must have measurable disease, defined as at least one lesion that can be
accurately measured in at least one dimension (longest diameter to be recorded) as
>10 mm with spiral CT scan. See section 11.2 for the evaluation of measurable
disease.

- Age > 18 years.

- Life expectancy of greater than 12 weeks.

- ECOG performance status ≤ 1 (see Appendix A).

- 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

- total bilirubin < 1.5 X institutional upper limit of normal

- AST (SGOT)/ALT (SGPT) < 1.5 X institutional upper limit of normal

- alkaline phosphatase < 2.5 X institutional upper limit of normal

- creatinine < 1.5 X institutional upper limit of normal OR

- estimated creatinine clearance > 60 mL/min/1.73 m2 for patients with creatinine
levels above institutional normal

- random blood glucose < 300 mg/dl OR fasting blood glucose < 200 mg/dl

- Cisplatin and docetaxel are known to be teratogenic. Women of child-bearing 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 may not be receiving any other investigational agents.

- Patients must not have received prior systemic chemotherapy or radiation therapy for
lung cancer. Prior systemic chemotherapy or radiation for other malignancies over 3
years prior to study enrollment may be allowed at the discretion of the principal
medical investigator.

- Prior malignancy in the past 3 years, other than non-melanoma skin cancer and in situ
carcinoma of the cervix.

- Patients who report a hearing deficit at baseline, even if it does not require a
hearing aid or intervention, or interfere with activities of daily life (CTCAE grade
2 or higher).

- Peripheral neuropathy > grade 1.

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

- Uncontrolled intercurrent illness including, but not limited to, ongoing or active
infection, uncontrolled diabetes, 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 both cisplatin and docetaxel have
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 cisplatin and docetaxel, breastfeeding should be discontinued if the
mother is treated with cisplatin and docetaxel.

- HIV-positive patients on combination antiretroviral therapy are ineligible because of
the potential for pharmacokinetic interactions with docetaxel. In addition, these
patients are at increased risk of lethal infections when treated with
marrow-suppressive therapy. Appropriate studies will be undertaken in patients
receiving combination antiretroviral therapy when indicated.

- Inability to comply with study and/or follow-up procedure