- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01118676
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.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
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-
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Toulouse, France, 31000
- Institut Claudius Regaud
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Toulouse, France, 31000
- CHU Toulouse Larrey
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
|
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To determine the Maximum Tolerated dose (MTD) of Cilengitide administered as continuous infusion during standard radiochemotherapy
Time Frame: at the end of the trial
|
at the end of the trial
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To determine the rate of objective response according to RECIST and pathological response.
Time Frame: at the end of the trial
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at the end of the trial
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To determine the survival free of metastases and the survival without local relapse at one year.
Time Frame: at the end of the trial
|
at the end of the trial
|
To determine the overall survival
Time Frame: at the end of the trial
|
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.
Time Frame: at the end of the trial
|
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.
Time Frame: at the end of the trial
|
at the end of the trial
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Elizabeth COHEN-JONATHAN MOYAL, Pr, Institut Claudius Regaud
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 07 POUM 01
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