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

Primary Purpose

Locally Advanced Non Small Cell Lung Cancer (NSCLC)

Status

Completed

Phase

Phase 1

Locations

France

Study Type

Interventional

Intervention

cilengitide, radiochemotherapy

About this trial

This is an interventional treatment trial for Locally Advanced Non Small Cell Lung Cancer (NSCLC) focused on measuring locally advanced non small cell lung cancer (NSCLC), locally advanced, Phase I, Cilengitide, concomitant radiochemotherapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

CHU Toulouse Larrey
Institut Claudius Regaud

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Cilengitide with standard radiochemotherapy

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

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

To determine the overall survival

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.

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

Full Information

NCT ID

NCT01118676

First Posted

May 5, 2010

Last Updated

May 17, 2022

Sponsor

Institut Claudius Regaud

Collaborators

Merck KGaA, Darmstadt, Germany

1. Study Identification

Unique Protocol Identification Number

NCT01118676

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2015

Overall Recruitment Status

Completed

Study Start Date

March 2010 (undefined)

Primary Completion Date

April 2015 (Actual)

Study Completion Date

April 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Institut Claudius Regaud

Collaborators

Merck KGaA, Darmstadt, Germany

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Locally Advanced Non Small Cell Lung Cancer (NSCLC)

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

14 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Cilengitide with standard radiochemotherapy

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

cilengitide, radiochemotherapy

Intervention Description

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 Outcome Measure Information:

Title

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 Outcome Measure Information:

Title

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

Time Frame

at the end of the trial

Title

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

Time Frame

at the end of the trial

Title

To determine the overall survival

Time Frame

at the end of the trial

Title

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

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Elizabeth COHEN-JONATHAN MOYAL, Pr

Organizational Affiliation

Institut Claudius Regaud

Official's Role

Principal Investigator

Facility Information:

Facility Name

CHU Toulouse Larrey

City

Toulouse

ZIP/Postal Code

31000

Country

France

Facility Name

Institut Claudius Regaud

City

Toulouse

ZIP/Postal Code

31000

Country

France

12. IPD Sharing Statement

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

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