Dose Escalation of Xeloda or 5FU Continuous Infusion in Combination With Taxotere and Concurrent Once Weekly, Hypofractionated Chest Radiotherapy for Advanced Non Small Cell Lung Cancer: A Phase I/II Study

Inclusion Criteria:

1. Patients must have histologic evidence of NSCLC. Patients with bronchoalveolar type
of NSCLCA are not eligible.

2. Should a second malignancy be present or discovered, subjects will only be eligible
if the NSCLCA is determined by the PI to be the more life-threatening disease
compared to the other malignancy in regards of life-expectancy.

3. All patients must have locally advanced disease (stage III A or III B) or metastatic
(stage 4). Other stages are not eligible.

4. Performance status of 0 –1 (ECOG Criteria).

5. Patients should have an absolute granulocyte count > 1000/mm3 and a platelet count >
80,000/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 > 2 x ULN and alkaline phosphatase >
2.5 x ULN are not eligible for this study.

7. Subjects with with severe renal impairment (creatinine clearance below 30 mL/min
[Cockroft and Gault]) are ineligible.

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

9. 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.

10. Patients with medically uncontrollable hypercoagalbility syndromes are not eligible.
Patients who are on therapeutic anticoagulation are not excluded.

11. Patients with pre-existing serious adverse effects to 5-FU are not eligible for this
study. Specifically, subjects with prior unanticipated severe reaction to
fluoropyrimidine therapy or known hypersensitivity to 5–fluorouracil.

12. Patients with medical contraindications to Taxanes are not eligible.

13. 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.

14. Subjects where studies or clinical examination demonstrates lack of physical
integrity of the upper gastrointestinal tract, inability to swallow tablets or those
who have malabsorption syndrome are not eligible.

15. Subjects who have had an organ allograft are not eligible.

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

17. Pregnant women and nursing mothers are ineligible. Eligible patients of reproductive
age should use contraception. Woman of childbearing potential with either a positive
or no pregnancy test at baseline. Woman of childbearing potential not using a
reliable and appropriate contraceptive method. (Postmenopausal women must have been
amenorrheic for at least 12 months to be considered of non–childbearing potential).

18. Sexually active males unwilling to practice contraception during the study will not
be eligible.

19. Patients must be at least 18 years old.

20. Known HIV positive patients will not be eligible.

21. Patients with prior treatment of Taxotere, Xeloda or 5FU will not be eligible.