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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 2
18 Years
70 Years
Open (Enrolling)
Both
Non-Small-Cell Lung Carcinoma

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

rate of patients presenting at least one toxicity grade≥3 (excepted hematological toxicity and nausea-vomiting)

Outcome Time Frame:

End of concomitant treatment (Day 71)

Safety Issue:

Yes

Principal Investigator

Pierre FOURNEL, Dr

Investigator Role:

Principal Investigator

Investigator Affiliation:

CHU SAINT-ETIENNE

Authority:

France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

2008-03

NCT ID:

NCT00985855

Start Date:

September 2009

Completion Date:

December 2012

Related Keywords:

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

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