Phase I Trial Evaluating Continuous Infusion of Cilengitide Together With Radiochemotherapy in Patients With Locally Advanced Non Small Cell Lung Cancer
1. Histologically proven non small cell lung cancer
2. Inoperable tage IIIA or IIIB non small cell lung cancer
3. Age ≥ 18 years
4. PerfLife expectancy ≥6 months
5. Hematological function : neutrophils ≥1500/mm3 and platelets ≥ 100000/mm3
6. Hepatic function: Bilirubin within normal limits et AST and ALT ≤ 2 times the upper
limit of normal (ULN).
7. Renal function: Creatinine ≤ 1.5 times ULN.
8. Absence of cardiac insufficiency, absence of unstable angina, absence of arrythmia
9. Patient has health insurance coverage.
10. Signed informed consent.
1. Patients previously treated for a malignancy by means of chemotherapy, radiotherapy
2. Uncontrolled hypertension
3. Uncontrolled bleeding within the last 3 months.
4. Patients under anti-coagulation with anti-vitamin K or therapeutic dose heparin ;
low-molecular heparins for prophylaxis are permitted and are not considered an
5. Presence of cerebral metastases.
6. Participation in a clinical trial within the last 8 weeks.
7. Any other specific concomitant anti-tumor treatment (such as chemotherapy,
8. Patients with a history of myocardial infarction or a cerebral vascular accident
within the last 12 months.
9. Continued use of aspirin (>325mg/day)
10. Major surgery whiting the last 28 days or planned.
11. Major non-healing wound, ulcer
12. Pregnant or breastfeeding women cannot participate in this trial. Women of
reproductive potential must have a negative pregnancy test (blood) within 72 hours
before the start of treatment.
13. Men and women of reproductive potential must use an efficient contraceptive method
when entering the trial and until one months after the end of treatment.
14. History of a thrombo-embolic or hemorrhagic event.
15. Patients put under tutelage.
16. Patients not able to follow the procedures visits, exams foreseen by the trial.
17. Any other severe medical or psychiatric condition or biological anomaly - acute or
chronic - that, in the investigator's opinion - may render the inclusion of the