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
  Purpose

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.


Condition Intervention Phase
Locally Advanced Non Small Cell Lung Cancer (NSCLC)*
Drug: cilengitide, radiochemotherapy
Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase I Trial Evaluating Continuous Infusion of Cilengitide Together With Radiochemotherapy in Patients With Locally Advanced Non Small Cell Lung Cancer

Resource links provided by NLM:


Further study details as provided by Institut Claudius Regaud:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 24
Study Start Date: March 2010
Estimated Study Completion Date: July 2016
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.


  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01118676

Locations
France
CHU Toulouse Larrey
Toulouse, France, 31000
Institut Claudius Regaud
Toulouse, France, 31000
Sponsors and Collaborators
Institut Claudius Regaud
Merck KGaA
Investigators
Principal Investigator: Elizabeth COHEN-JONATHAN MOYAL, Pr Institut Claudius Regaud
  More Information

No publications provided

Responsible Party: Institut Claudius Regaud
ClinicalTrials.gov Identifier: NCT01118676     History of Changes
Other Study ID Numbers: 07 POUM 01
Study First Received: May 5, 2010
Last Updated: September 11, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Institut Claudius Regaud:
locally advanced non small cell lung cancer (NSCLC), locally advanced, Phase I, Cilengitide, concomitant radiochemotherapy

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms

ClinicalTrials.gov processed this record on September 18, 2014