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

• Status: Completed
• Trial end date: 2011-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Institut de Cancérologie de la Loire
• Treatments: Cetuximab; Cisplatin; Etoposide; Etoposide phosphate; Vinorelbine

Criteria

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