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

NCT00985855 | Completed Phase 2 DMC

• 2 other identifiers: 2008-032008-005013-21
• Study Type: interventional
• Target: 91
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Non-Small-Cell Lung Carcinoma

Outcome Measures

Primary Outcomes (1)

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

  End of concomitant treatment (Day 71)

Study Arms (2)

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.

Drug: cisplatin, vinorlebine, cetuximab

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.

Drug: cisplatine, etoposide, cetuximab

Interventions

cisplatin, vinorlebine, cetuximab DRUG

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

Cisplatin, vinorelbine

cisplatine, etoposide, cetuximab DRUG

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, etoposide

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Institut de Cancérologie de la Loire: lead

Study Sites (1)

Institut de Cancerologie de la Loire

Saint-Priest-en-Jarez, 42271, France

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Cisplatin; Cetuximab; Etoposide

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Glucosides; Glycosides; Carbohydrates

Study Officials

• Pierre FOURNEL, Dr

  CHU SAINT-ETIENNE

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2009
• First Posted: September 29, 2009
• Study Start: September 1, 2009
• Primary Completion: August 1, 2011
• Study Completion: August 1, 2011
• Last Updated: September 14, 2017

Record last verified: 2011-01

Locations

FR (1)