1. Pathologically or cytologically confirmed NSCLC. Histology may include
adenocarcinoma, squamous cell, large cell undifferentiated, but no bronchoalveolar
carcinoma, small cell or carcinoid.
2. Locally advanced NSCLC disease (Stage IIIa or IIIb) or metastatic disease (Stage IV)
3. ECOG performance status 0-2 (See Appendix 1 )
4. Age > 18 years.
5. Absoloute neutrophil count > 1500 / mm3 ,platelet count > 100,000/ mm3
6. Serum bilirubin < upper limit of normal (ULN); ALT and AST < 2.5 X ULN if alkaline
phosphatase is < ULN. Alkaline phosphatase may be up to 4 X ULN if transaminases are
7. Normal serum creatinine (less than 1.5 mg/dl) or creatinine clearance greater than 30
ml/minute (Cockroft and Gault).
8. No history of allergy to the agents being used in this study.
9. If female of childbearing potential, pregnancy test is negative and must be
practicing approved methods of birth control. (Postmenopausal women must have been
amenorrheic for at least 12 months to be considered of nonchildbearing potential).
10. If fertile, the patient agrees to use acceptable methods to avoid pregnancy for the
duration of the study.
11. No evidence of CHF, ischemic heart disease (NYHA Class III or IV), or serious
arrhythmias or recent history of myocardial infarction.
12. No evidence of active infection or serious concurrent medical illness which would
jeopardize the ability of the patient to receive with reasonable safety the
chemotherapy and radiation program outlined in this protocol.
13. 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.
14. Patients should have at least a predicted FEV1 of 30%.
15. Signed informed consent has been obtained (see the informed consent form Appendix 2).
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
3.B. Exclusion Criteria Patients meeting any of the following criteria will not be
eligible for the study.
1. Patients with medically uncontrollable hypercoaguability syndromes are not eligible.
Patients who are on therapeutic anticoagulation are not excluded.
2. Patients with weight loss > 10% in previous 3 months.
3. Patients with prior Vinca Alkaloid treatment.
4. Subjects where studies or clinical examination demonstrates lack of physical
integrity of the upper gastrointestinal tract (e.g. previous significant surgical
resection), inability to swallow capsules intact, dysphagia, or those who have
5. Subjects who have had an organ allograft.
6. Patients with known adverse effects to Vinca Alkaloids.
7. Subjects with several renal impairment (creatinine clearance below 30ml/min [Cockroft
8. Pregnant women and nursing mothers.
9. Sexually active males unwilling to practice contraception during the study.