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

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

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.

Study Overview

• Status: Completed
• Conditions: Non-Small-Cell Lung Carcinoma
• Intervention / Treatment: Drug: cisplatin, vinorlebine, cetuximab; Drug: cisplatine, etoposide, cetuximab

• Study Type: Interventional
• Enrollment (Actual): 91
• Phase: Phase 2

Contacts and Locations

Study Locations

• France
  • St Priest en Jarez, France, 42271
    • Institut de Cancerologie de La Loire

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cisplatin, vinorelbine; patients will receive induction chemotherapy (cisplatin, docetaxel) followed by a concomitant radio-chemothérapy including 2 cycles of cisplatin and vinorelbine associated with a weekly cetuximab infusion during the radiotherapy.	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
Experimental: Cisplatin, etoposide; patients will receive induction chemotherapy (cisplatin, docetaxel) followed by a concomitant radio-chemothérapy including 2 cycles of cisplatin and etoposide associated with a weekly cetuximab infusion during the radiotherapy.	Drug: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
rate of patients presenting at least one toxicity grade≥3 (excepted hematological toxicity and nausea-vomiting)	End of concomitant treatment (Day 71)

Collaborators and Investigators

• Sponsor: Institut de Cancérologie de la Loire
• Investigators: Principal Investigator: Pierre FOURNEL, Dr, CHU SAINT-ETIENNE

Study record dates

Study Major Dates

• Study Start: September 1, 2009
• Primary Completion (Actual): August 1, 2011
• Study Completion (Actual): August 1, 2011

Study Registration Dates

• First Submitted: September 22, 2009
• First Submitted That Met QC Criteria: September 28, 2009
• First Posted (Estimate): September 29, 2009

Study Record Updates

• Last Update Posted (Actual): September 14, 2017
• Last Update Submitted That Met QC Criteria: September 13, 2017
• Last Verified: January 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Antineoplastic Agents, Phytogenic; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Antineoplastic Agents, Immunological; Etoposide; Cetuximab
• Other Study ID Numbers: 2008-03; 2008-005013-21 (EudraCT Number)