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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00985855
First Posted: September 29, 2009
Last Update Posted: September 14, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Institut de Cancérologie de la Loire
  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
Intervention Model: Parallel Assignment
Masking: None (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:


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) ]

Enrollment: 91
Study Start Date: September 2009
Study Completion Date: August 2011
Primary Completion Date: August 2011 (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

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00985855


Locations
France
Institut de Cancerologie de la Loire
St Priest en Jarez, France, 42271
Sponsors and Collaborators
Institut de Cancérologie de la Loire
Investigators
Principal Investigator: Pierre FOURNEL, Dr CHU SAINT-ETIENNE
  More Information

Responsible Party: Institut de Cancérologie de la Loire
ClinicalTrials.gov Identifier: NCT00985855     History of Changes
Other Study ID Numbers: 2008-03
2008-005013-21 ( EudraCT Number )
First Submitted: September 22, 2009
First Posted: September 29, 2009
Last Update Posted: September 14, 2017
Last Verified: January 2011

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Etoposide phosphate
Vinorelbine
Cisplatin
Cetuximab
Etoposide
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action