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Phase I Trial Evaluating Continuous Infusion of Cilengitide Together With Radiochemotherapy in Patients With Locally Advanced Non Small Cell Lung Cancer

Phase 1
18 Years
Open (Enrolling)
Locally Advanced Non Small Cell Lung Cancer (NSCLC)*

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Trial Information

Phase I Trial Evaluating Continuous Infusion of Cilengitide Together With Radiochemotherapy in Patients With Locally Advanced Non Small Cell Lung Cancer

Inclusion Criteria:

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.

Exclusion Criteria:

1. Patients previously treated for a malignancy by means of chemotherapy, radiotherapy
or surgery.

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
exclusion criterion.

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,
radiotherapy …).

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
patient inappropriate.

Type of Study:


Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To determine the Maximum Tolerated dose (MTD) of Cilengitide administered as continuous infusion during standard radiochemotherapy

Outcome Time Frame:

at the end of the trial

Safety Issue:


Principal Investigator


Investigator Role:

Principal Investigator

Investigator Affiliation:

Institut Claudius Regaud


France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

07 POUM 01



Start Date:

March 2010

Completion Date:

August 2013

Related Keywords:

  • Locally Advanced Non Small Cell Lung Cancer (NSCLC)*
  • locally advanced non small cell lung cancer (NSCLC), locally advanced, Phase I, Cilengitide, concomitant radiochemotherapy
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms