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

NCT01118676 | Completed Phase 1

• 1 other identifier: 07 POUM 01
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 2

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)

Keywords

locally advanced non small cell lung cancer (NSCLC), locally advanced, Phase I, Cilengitide, concomitant radiochemotherapy

Outcome Measures

Primary Outcomes (1)

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

  at the end of the trial

Secondary Outcomes (5)

• To determine the rate of objective response according to RECIST and pathological response.

  at the end of the trial

• To determine the survival free of metastases and the survival without local relapse at one year.

  at the end of the trial

• To determine the overall survival

  at the end of the trial

• To determine the toxicity of the combination of radiochemotherapy and continuous infusion cilengitide as well as the toxicity of the combination of chemotherapy and twice weekly cilengitide.

  at the end of the trial

• Ancillary studies will be undertaken to determine factors predictive of response to treatment and to characterize the anti-angiogenic effect of Cilengitide.

  at the end of the trial

Study Arms (1)

Cilengitide with standard radiochemotherapy

EXPERIMENTAL

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.

Drug: cilengitide, radiochemotherapy

Interventions

cilengitide, radiochemotherapy 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.

Cilengitide with standard radiochemotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically proven non small cell lung cancer
• Inoperable tage IIIA or IIIB non small cell lung cancer
• Age ≥ 18 years
• PerfLife expectancy ≥6 months
• Hematological function : neutrophils ≥1500/mm3 and platelets ≥ 100000/mm3
• Hepatic function: Bilirubin within normal limits et AST and ALT ≤ 2 times the upper limit of normal (ULN).
• Renal function: Creatinine ≤ 1.5 times ULN.
• Absence of cardiac insufficiency, absence of unstable angina, absence of arrythmia
• Patient has health insurance coverage.
• Signed informed consent.

You may not qualify if:

• Patients previously treated for a malignancy by means of chemotherapy, radiotherapy or surgery.
• Uncontrolled hypertension
• Uncontrolled bleeding within the last 3 months.
• Presence of cerebral metastases.
• Participation in a clinical trial within the last 8 weeks.
• Any other specific concomitant anti-tumor treatment (such as chemotherapy, radiotherapy …).
• Patients with a history of myocardial infarction or a cerebral vascular accident within the last 12 months.
• Continued use of aspirin (\>325mg/day)
• Major surgery whiting the last 28 days or planned.
• Major non-healing wound, ulcer
• 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.
• 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.
• History of a thrombo-embolic or hemorrhagic event.
• Patients put under tutelage.
• Patients not able to follow the procedures visits, exams foreseen by the trial.

Sponsors & Collaborators

• Institut Claudius Regaud: lead
• Merck KGaA, Darmstadt, Germany: collaborator

Study Sites (2)

CHU Toulouse Larrey

Toulouse, 31000, France

Location

Institut Claudius Regaud

Toulouse, 31000, France

Location

Related Publications (1)

• Massabeau C, Khalifa J, Filleron T, Modesto A, Bigay-Game L, Plat G, Dierickx L, Aziza R, Rouquette I, Gomez-Roca C, Mounier M, Delord JP, Toulas C, Olivier P, Chatelut E, Mazieres J, Cohen-Jonathan Moyal E. Continuous Infusion of Cilengitide Plus Chemoradiotherapy for Patients With Stage III Non-Small-cell Lung Cancer: A Phase I Study. Clin Lung Cancer. 2018 May;19(3):e277-e285. doi: 10.1016/j.cllc.2017.11.002. Epub 2017 Nov 21.

  PMID: 29221762 RESULT

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Cilengitide; Chemoradiotherapy

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Drug Therapy; Radiotherapy

Study Officials

• Elizabeth COHEN-JONATHAN MOYAL, Pr

  Institut Claudius Regaud

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2010
• First Posted: May 7, 2010
• Study Start: March 1, 2010
• Primary Completion: April 1, 2015
• Study Completion: April 1, 2015
• Last Updated: April 14, 2026

Record last verified: 2026-04

Locations

FR (2)