Cilengitide Together With Radiochemotherapy in Patients With Locally Advanced Non Small Cell Lung Cancer

NCT ID: NCT01118676

Last Updated: 2022-05-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-03-31
• Study Completion Date: 2015-04-30

Brief Summary

This is a two-center study which includes 24 patients maximum on 36 months : 24 months accrual - 12 months follow up.

Eligible patients are included according to a standard 3+3 design.

Patients included in the trial will be treated with a combination of radiochemotherapy (standard radiotherapy of 66 Gy, 2 Gy per daily fraction, and cisplatin and vinorelbine based chemotherapy).

Cilengitide will be administered alone as continuous infusion two weeks before the radiochemotherapy and will then be continued during radiochemotherapy as continuous infusion.

The dose levels investigated will be applied to the continuous administration (a maximum of 4 dose levels).

After the end of concomitant radiochemotherapy, cilengitide will be administered i.v. at a dose of 2000 mg twice weekly until the end of chemotherapy.

The dose of Cilengitide administered after radiotherapy will not be increased. 4 dose levels are defined:12, 18, 27 et 40 mg /hour.

Conditions

Locally Advanced Non Small Cell Lung Cancer (NSCLC)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cilengitide with standard radiochemotherapy

Cilengitide (4 dose levels are defined :12, 18, 27 et 40 mg /hour) concomitant with radiotherapy (standard radiotherapy of 66 Gy, 2 Gy per daily fraction) and cisplatin and vinorelbine based chemotherapy.

Group Type: EXPERIMENTAL

cilengitide, radiochemotherapy

Intervention Type: DRUG

Cilengitide will be administered alone as continuous infusion two weeks before the radiochemotherapy and will then be continued during radiochemotherapy (standard radiotherapy of 66 Gy, 2 Gy per daily fraction, and cisplatin and vinorelbine based chemotherapy)as continuous infusion.

The dose levels investigated will be applied to the continuous administration of cilengitide(a maximum of 4 dose levels : 12, 18, 27 et 40 mg /hour).

After the end of concomitant radiochemotherapy, cilengitide will be administered i.v. at a dose of 2000 mg twice weekly until the end of chemotherapy.

Interventions

cilengitide, radiochemotherapy

Cilengitide will be administered alone as continuous infusion two weeks before the radiochemotherapy and will then be continued during radiochemotherapy (standard radiotherapy of 66 Gy, 2 Gy per daily fraction, and cisplatin and vinorelbine based chemotherapy)as continuous infusion.

The dose levels investigated will be applied to the continuous administration of cilengitide(a maximum of 4 dose levels : 12, 18, 27 et 40 mg /hour).

After the end of concomitant radiochemotherapy, cilengitide will be administered i.v. at a dose of 2000 mg twice weekly until the end of chemotherapy.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck KGaA, Darmstadt, Germany

INDUSTRY

Sponsor Role: collaborator

Institut Claudius Regaud

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Elizabeth COHEN-JONATHAN MOYAL, Pr

Role: PRINCIPAL_INVESTIGATOR

Institut Claudius Regaud

Locations

CHU Toulouse Larrey

Toulouse, , France

Institut Claudius Regaud

Toulouse, , France

Countries

France

Other Identifiers

07 POUM 01

Identifier Type: -

Identifier Source: org_study_id