Combination of Weekly Radiation and Docetaxel for Locally Advanced Non Small Cell Lung Cancer: A Feasibility Study

Inclusion Criteria:

1. Patients must have histologic evidence of NSCLC.

2. Should the patient have a history of another malignancy or a second malignancy be
present or discovered, subjects will only be eligible if the NSCLC is determined by
the PI to be the more life-threatening disease and the other malignancy would not
have otherwise a significant impact on the subjects life-expectancy (e.g. basal cell
carcinoma of skin, remote history of early stage breast cancer surgically cured).

3. All patients must have surgically incurable disease, i.e. locally advanced disease
(stage III A or III B) or metastatic stage IV.

4. Performance status of 0 to 2 (ECOG Criteria).

5. Patients should have an absolute granulocyte count > 1500/mm3 and a platelet count >
100,000/mm3.

6. Patients should have adequate hepatic function as indicated by a serum bilirubin <
upper limit of normal (ULN); ALT and AST <2.5 ULN if alkaline phosphatase is < ULN.
Alkaline phosphatase may be up to 4 x ULN if transaminases are < ULN. However,
patients who have both transaminase elevation > 1.5 x ULN and alkaline phosphatase >
2.5 x ULN are not eligible for this study.

7. Patients should have at least a predicted FEV1 of 30%.

8. Patients with active ischemic heart disease (NYHA Class III or IV), congestive heart
failure, symptomatic arrythmias, or a recent history of a myocardial infarction are
excluded.

9. Patients with pre-existing neuropathy (> grade 1) are not eligible for this study.

10. No other serious concurrent medical illness or active infection which would
jeopardize the ability of the patient to receive with reasonable safety the
chemotherapy and surgery program outlined in this protocol is allowed.

11. Signed informed consent: each patient must be aware of the neoplastic nature of
his/her disease and willingly consent to participate in the study after being
informed of the procedure to be followed, the experimental nature of the therapy,
alternatives, potential benefits, side effects, risks, and discomforts.

12. Pregnant women and nursing mothers are ineligible. Women of child-bearing potential
must have a negative pregnancy test. Women of childbearing potential must be willing
to consent to using effective contraception while on treatment and for three months
thereafter.

13. Patients with a history of severe hypersensitivity reaction to TaxotereÒ or other
drugs formulated with polysorbate 80 must be excluded.

14. Patients must be at least 18 years old.

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Exclusion Criteria:

Not falling into the eligibility criteria outlined above