Trial | NCT00985855  Report issue

Title

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

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    91
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 Started
Sep 30
2009
Primary Completion
Aug 31
2011
Study Completion
Aug 31
2011
Last Update
Sep 14
2017

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

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

Cisplatin, vinorelbine Experimental

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.

Cisplatin, etoposide Experimental

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.

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
No Results Posted