Feasibility of Cetuximab Associated With Concomitant Radio-Chemotherapy in Patients With Locally Advanced Non Small Cell Lung Cancer

Non-Small-Cell Lung Carcinoma Clinical Trial

Official title:

Feasibility of Cetuximab (ERBITUX®) Associated With Concomitant Radio-chemotherapy in Patients With Locally Advanced Non Small Cell Lung Cancer: a Phase II, Randomised Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00985855
• Other study ID #: 2008-03
• Secondary ID: 2008-005013-21
• Status: Completed
• Phase: Phase 2
• First received: September 22, 2009
• Last updated: September 13, 2017
• Start date: September 2009
• Est. completion date: August 2011

Study information

• Verified date: January 2011
• Source: Institut de Cancérologie de la Loire
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Phase II, randomised, controlled, non comparative study with 2 parallel groups:

• Arm A: patients will receive induction chemotherapy (cisplatin and docetaxel) followed by a concomitant radio-chemotherapy including 2 cycles of cisplatin and vinorelbine associated with a weekly cetuximab infusion during the radiotherapy.

• Arm B: patients will receive induction chemotherapy (cisplatin and docetaxel) followed by a concomitant radio-chemothérapy including 2 cycles of cisplatin and etoposide associated with a weekly cetuximab infusion during the radiotherapy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 91
• Est. completion date: August 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Non-Small-Cell Lung cancer cytologically or histologically proved

• Stage III AN2 inoperable or non resectable

• presence of at least one one dimension measurable target (at least 10 mm with spiral tomodensitometry)

• Possibility to include all targets in one irradiation field

• Age of 18 to 70

• Patients non previously treated

• Performance Status 0 or 1

• Loss of weight =10% in the 3 last months

• Neutrophil = 1500/mm3 and platelets = 100000/mm3

• Creatinine clearance = 60 ml/min

• total bilirubin = 1,5N and ASAT ALAT = 2,5N

• Respiratory function normal: VEMS = 40% theorical, DLCO/VA = 50% theorical and PaO2 = 60 mmHg

• Signed inform consent form

• Compliance to radiotherapy 66 Gy with dosimetry V20 = 35% and pulmonary mean dose=20 Gy

Exclusion Criteria:

• Pretreated bronchial carcinoma, excepted endoscopic deobstruction

• operable bronchial carcinoma

• small cell lung cancer, composite cancer, neuroendocrine cancer, broncho alveolar cancer

• superior vena cava syndroms

• puncturable pleural effusion

• metastatic lung cancer

• Stage IIIb cancer with neoplastic pericarditis

• Previous thoracic irradiation

• severe cardiac disease in the 12 months before inclusion

• interstitial lung disease

• anti-EGFR and anti-VEGF treatments

• hypersensitivity to murine proteins and allergies to protocol drugs

• uncontrolled infectious state

• HIV patient

• corticoid definitive contraindication

• péripheric neuropathy grade=2

• neurologic, psychiatric and organic disorder

• past or concomitant cancer excepted treated skin baso-cellular cancer or in situ cervical cancer, or any cancer only surgically treated for 5 years

• breastfeeding woman

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-Small-Cell Lung Carcinoma

Intervention

Drug:
• cisplatin, vinorlebine, cetuximab
patient will receive 2 cycles of cisplatine 80 mg/m² at day 29 and day 50 more vinorelbine 15 mg/m² at day 29, day 36 and day 50 and 57 associated to cetuximab 400 mg/m² at day: 22,29, 36, 43, 50, 57, 64 and 71
• cisplatine, etoposide, cetuximab
patient will receive 2 cycles of cisplatine 50 mg/m² at day 29, 36, 57, and 64 + étoposide 50mg/m² during day 29-33, day 57-61associated to cetuximab 400 mg/m² at day: 22,29, 36, 43, 50, 57, 64 and 71

Locations

Country	Name	City	State
France	Institut de Cancerologie de la Loire	St Priest en Jarez

Sponsors (1)

Lead Sponsor	Collaborator
Institut de Cancérologie de la Loire

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	rate of patients presenting at least one toxicity grade=3 (excepted hematological toxicity and nausea-vomiting)		End of concomitant treatment (Day 71)