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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
History of Changes
  Purpose

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.

Condition Intervention Phase
Non-Small-Cell Lung Carcinoma
 Drug: cisplatin, vinorlebine, cetuximab
Drug: cisplatine, etoposide, cetuximab
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Feasibility of Cetuximab (ERBITUX®) Associated With Concomitant Radio-chemotherapy in Patients With Locally Advanced Non Small Cell Lung Cancer: a Phase II, Randomised Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Institut de Cancérologie de la Loire:

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 62
Study Start Date: September 2009
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00985855

Contacts
Contact: Pierre Fournel, MD +33(0)4917036 pierre.fournel@icloire.fr

Locations
France
Institut de Cancerologie de la Loire Recruiting
St Priest en Jarez, France, 42271
Contact: Pierre Fournel, MD     +33(0)477917036     pierre.fournel@icloire.fr    
Principal Investigator: Pierre Fournel, MD            
Sponsors and Collaborators
Institut de Cancérologie de la Loire
Investigators
Principal Investigator: Pierre FOURNEL, Dr CHU SAINT-ETIENNE
  More Information

No publications provided

Responsible Party: Pierre FOURNEL (MD), Institut de Cancérologie de la Loire
ClinicalTrials.gov Identifier: NCT00985855     History of Changes
Other Study ID Numbers: 2008-03, 2008-005013-21
Study First Received: September 22, 2009
Last Updated: January 14, 2011
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
 Respiratory Tract Diseases
Etoposide phosphate
Vinorelbine
Cetuximab
Cisplatin
Etoposide
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on June 18, 2013