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Completed

NCT Number: NCT01118676

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

CHU Toulouse Larrey, Toulouse, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • Patients previously treated for a malignancy by means of chemotherapy, radiotherapy or surgery.
  • Uncontrolled hypertension
  • Uncontrolled bleeding within the last 3 months.
  • 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.
  • 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.
  • 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.

Treatment and study plan

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.

Primary outcomes

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

    Time frame: at the end of the trial

Secondary outcomes

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

    Time frame: at the end of the trial

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

    Time frame: at the end of the trial

  3. To determine the overall survival

    Time frame: at the end of the trial

  4. 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.

    Time frame: at the end of the trial

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

    Time frame: at the end of the trial

Sponsors and collaborators

Lead sponsor

Institut Claudius Regaud

Other

Collaborators

  • Merck KGaA, Darmstadt, Germany

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2015
Study completion
2015
First posted
May 7, 2010
Registry last updated
Apr 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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