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

This study has suspended participant recruitment.
Sponsor:
Collaborator:
Merck KGaA
Information provided by (Responsible Party):
Institut Claudius Regaud
ClinicalTrials.gov Identifier:
NCT01118676
First received: May 5, 2010
Last updated: September 11, 2014
Last verified: March 2014

May 5, 2010
September 11, 2014
March 2010
July 2015   (final data collection date for primary outcome measure)
To determine the Maximum Tolerated dose (MTD) of Cilengitide administered as continuous infusion during standard radiochemotherapy [ Time Frame: at the end of the trial ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01118676 on ClinicalTrials.gov Archive Site
  • To determine the rate of objective response according to RECIST and pathological response. [ Time Frame: at the end of the trial ] [ Designated as safety issue: No ]
  • To determine the survival free of metastases and the survival without local relapse at one year. [ Time Frame: at the end of the trial ] [ Designated as safety issue: No ]
  • To determine the overall survival [ Time Frame: at the end of the trial ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Cilengitide Together With Radiochemotherapy in Patients With Locally Advanced Non Small Cell Lung Cancer
Phase I Trial Evaluating Continuous Infusion of 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.

Not Provided
Interventional
Phase 1
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Locally Advanced Non Small Cell Lung Cancer (NSCLC)*
Drug: 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.

Experimental: 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.
Intervention: Drug: cilengitide, radiochemotherapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Suspended
24
July 2016
July 2015   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT01118676
07 POUM 01
No
Institut Claudius Regaud
Institut Claudius Regaud
Merck KGaA
Principal Investigator: Elizabeth COHEN-JONATHAN MOYAL, Pr Institut Claudius Regaud
Institut Claudius Regaud
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP