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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2011 by Institut de Cancérologie de la Loire.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Institut de Cancérologie de la Loire
ClinicalTrials.gov Identifier:
NCT00985855
First received: September 22, 2009
Last updated: January 14, 2011
Last verified: January 2011

September 22, 2009
January 14, 2011
September 2009
September 2012   (final data collection date for primary outcome measure)
rate of patients presenting at least one toxicity grade≥3 (excepted hematological toxicity and nausea-vomiting) [ Time Frame: End of concomitant treatment (Day 71) ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00985855 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Non-Small-Cell Lung Carcinoma
  • 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
  • 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.
    Intervention: Drug: cisplatin, vinorlebine, cetuximab
  • 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.
    Intervention: Drug: cisplatine, etoposide, cetuximab
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
62
December 2012
September 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 70 Years
No
Contact: Pierre Fournel, MD +33(0)4917036 pierre.fournel@icloire.fr
France
 
NCT00985855
2008-03, 2008-005013-21
Yes
Pierre FOURNEL (MD), Institut de Cancérologie de la Loire
Institut de Cancérologie de la Loire
Not Provided
Principal Investigator: Pierre FOURNEL, Dr CHU SAINT-ETIENNE
Institut de Cancérologie de la Loire
January 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP