Paclitaxel-bevacizumab in Advanced Lung Cancer
- Conditions
- Non-squamous Non-small Cell Lung Cancer
- Interventions
- Registration Number
- NCT01763671
- Lead Sponsor
- Intergroupe Francophone de Cancerologie Thoracique
- Brief Summary
The study objective is to evaluate the efficacy of paclitaxel-bevacizumab comparing to docetaxel.
Docetaxel is a standard treatment of 2nd or 3rd line in lung cancer. It was validated by numerous clinical trials but sometimes toxicities are difficult to manage.
Bevacizumab is an antiangiogenic treatment which was validated by numerous clinical trials in association with platinum in first ligne. Different clinical and preclinical data suggest that there could exist a synergy between paclitaxel and bevacizumab. This association is already used in metastatic breast cancer, it permits almost to double the response rate and progression free survival. In lung cancer, the association was evaluated by two retrospective studies which demonstrated a benefit with a favourable safety profile.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 166
- 2nd or 3rd line of non squamous non small cell lung cancer of stage III or IV
- Document progression at the time of the inclusion. At least, one previous chemotherapy line with platinum. Patient who had previous treatment with bevacizumab can be included.
- Patient with active mutation of EGFR must have had on line of chemotherapy with platinum and one with Tyrosine kinase inhibitor of EGFR.
- Patient with ALK rearrangement must have had at least one line of chemotherapy with platinum and one with crizotinib.
- Mixed cancer small cells and non small cells or squamous lung cancer.
- Central nervous system symptomatic metastasis or requiring immediate cerebral radiotherapy
- patient who have had previous treatment with taxane (docetaxel, paclitaxel). Peri-operatory chemotherapy or chemoradiotherapy with taxane allowed if stopped more than 6 months before.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Docetaxel Docetaxel - Paclitaxel - Bevacizumab Paclitaxel - Paclitaxel - Bevacizumab Bevacizumab -
- Primary Outcome Measures
Name Time Method Progression free survival about 4 months Time between inclusion and progression
- Secondary Outcome Measures
Name Time Method Response Rate At 8 weeks Overall survival about 8 months Time between inclusion and death
Trial Locations
- Locations (54)
CHI Créteil
🇫🇷Créteil, France
Hôpital Privé d'Antony
🇫🇷Antony, France
CH Compiègne - Pneumologie
🇫🇷Compiègne, France
CH Région Saint-Omer
🇫🇷Helfaut, France
CH
🇫🇷Colmar, France
Mulhouse - CH
🇫🇷Mulhouse, France
Bordeaux - Polyclinique Nord
🇫🇷Bordeaux, France
Castelnau Le Lez - Clinique
🇫🇷Castelnau, France
Caen - Centre François Baclesse
🇫🇷Caen, France
Centre Hospitalier
🇫🇷Annemasse, France
Hôpital Percy-Armées - Pneumologie
🇫🇷Clamart, France
CH de Longjumeau
🇫🇷Longjumeau, France
Paris - Saint Louis
🇫🇷Paris, France
CH de la Côte Basque
🇫🇷Bayonne, France
Caen - CHU Côte de Nacre
🇫🇷Caen, France
Chauny - CH
🇫🇷Chauny, France
Hôpitral Gabriel Montpied - Pneumologie
🇫🇷Clermont-Ferrand, France
CHRU Grenoble
🇫🇷Grenoble, France
Amiens - CHU
🇫🇷Amiens, France
Paris - Pitié-salpêtrière
🇫🇷Paris, France
Avignon - Institut Sainte-Catherine
🇫🇷Avignon, France
Béziers - CH
🇫🇷Béziers, France
CH de Chartres Hôpital Louis Pasteur
🇫🇷Chartres, France
CH de Macon
🇫🇷Macon, France
Le Mans - Centre Hospitalier
🇫🇷Le Mans, France
CHU (Hôpital Calmette) - Pneumologie
🇫🇷Lille, France
Nantes - Centre René Gauducheau
🇫🇷Nantes, France
Lyon - Hôpital Jean Mermoz
🇫🇷Lyon, France
Hopital Tenon - Pneumologie
🇫🇷Paris, France
Lorient - CHBS
🇫🇷Lorient, France
Toulon - CHI
🇫🇷Toulon, France
Toulon - HIA
🇫🇷Toulon, France
Suresnes - Hopital Foch
🇫🇷Suresnes, France
Mantes La Jolie - CH
🇫🇷Mantes La Jolie, France
Marseille - Hôpital Sainte Marguerite
🇫🇷Marseille, France
Maubeuge - Polyclinique du Parc
🇫🇷Maubeuge, France
CH Montélimar
🇫🇷Montélimar, France
CHR d'Orléans La Source
🇫🇷Orléans, France
Pau - CH
🇫🇷Pau, France
HIA Val-de-Grâce
🇫🇷Paris, France
Hôpital Bichat - Claude - Bernard
🇫🇷Paris, France
Lyon Sud
🇫🇷Pierre Bénite, France
Saint Quentin - CH
🇫🇷Saint Quentin, France
CHU Saint-Etienne Pneumologie
🇫🇷Saint-Etienne, France
Rouen - CHU
🇫🇷Rouen, France
Strasbourg - NHC
🇫🇷Strasbourg, France
Toulouse - CHU Larrey
🇫🇷Toulouse, France
Tours - CHU
🇫🇷Tours, France
Valenciennes - Clinique
🇫🇷Valenciennes, France
CH de Villefranche - Pneumologie
🇫🇷Villefranche, France
Institut Gustave Roussy
🇫🇷Villejuif, France
Harfleur - Clinique du Petit Colmoulins
🇫🇷Harfleur, France
Lyon - Hôpital Louis Pradel (Pneumologie)
🇫🇷Lyon, France
Thonon les bains - CH
🇫🇷Thonon les bains, France