Clinical trial NCT01763671: Paclitaxel-bevacizumab in Advanced Lung Cancer
Official title: Phase III Study Comparing the Efficacy of Paclitaxel-bevacizumab With Docetaxel in 2nd or 3rd Line of Treatment of Non Squamous Non Small Cells Lung Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Non-squamous Non-small Cell Lung Cancer
Keywords: Lung cancer
Paclitaxel bevacizumab
IFCT
Lead sponsor: Intergroupe Francophone de Cancerologie Thoracique
Sponsor class: OTHER
First posted: 2013-01-09
Enrollment: 166
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Progression free survival
timeFrame: about 4 months
Secondary outcomes:
measure: Response Rate
timeFrame: At 8 weeks
measure: Overall survival
timeFrame: about 8 months
Other outcomes:
Locations:
city: Amiens
country: France
facility: Amiens - CHU
city: Annemasse
country: France
facility: Centre Hospitalier
city: Antony
country: France
facility: Hôpital Privé d'Antony
city: Avignon
country: France
facility: Avignon - Institut Sainte-Catherine
city: Bayonne
country: France
facility: CH de la Côte Basque
city: Bordeaux
country: France
facility: Bordeaux - Polyclinique Nord
city: Béziers
country: France
facility: Béziers - CH
city: Caen
country: France
facility: Caen - Centre François Baclesse
city: Caen
country: France
facility: Caen - CHU Côte de Nacre
city: Castelnau
country: France
facility: Castelnau Le Lez - Clinique
city: Chartres
country: France
facility: CH de Chartres Hôpital Louis Pasteur
city: Chauny
country: France
facility: Chauny - CH
city: Cholet
country: France
facility: CH
city: Clamart
country: France
facility: Hôpital Percy-Armées - Pneumologie
city: Clermont-Ferrand
country: France
facility: Hôpitral Gabriel Montpied - Pneumologie
city: Colmar
country: France
facility: CH
city: Compiègne
country: France
facility: CH Compiègne - Pneumologie
city: Créteil
country: France
facility: CHI Créteil
city: Grenoble
country: France
facility: CHRU Grenoble
city: Harfleur
country: France
facility: Harfleur - Clinique du Petit Colmoulins
city: Helfaut
country: France
facility: CH Région Saint-Omer
city: Le Mans
country: France
facility: Le Mans - Centre Hospitalier
city: Lille
country: France
facility: CHU (Hôpital Calmette) - Pneumologie
city: Longjumeau
country: France
facility: CH de Longjumeau
city: Lorient
country: France
facility: Lorient - CHBS
city: Lyon
country: France
facility: Lyon - Hôpital Jean Mermoz
city: Lyon
country: France
facility: Lyon - Hôpital Louis Pradel (Pneumologie)
city: Macon
country: France
facility: CH de Macon
city: Mantes La Jolie
country: France
facility: Mantes La Jolie - CH
city: Marseille
country: France
facility: Marseille - Hôpital Sainte Marguerite
city: Maubeuge
country: France
facility: Maubeuge - Polyclinique du Parc
city: Montélimar
country: France
facility: CH Montélimar
city: Mulhouse
country: France
facility: Mulhouse - CH
city: Nantes
country: France
facility: Nantes - Centre René Gauducheau
city: Orléans
country: France
facility: CHR d'Orléans La Source
city: Paris
country: France
facility: Paris - Saint Louis
city: Paris
country: France
facility: Hopital Tenon - Pneumologie
city: Paris
country: France
facility: HIA Val-de-Grâce
city: Paris
country: France
facility: Hôpital Bichat - Claude - Bernard
city: Paris
country: France
facility: Paris - Pitié-salpêtrière
city: Pau
country: France
facility: Pau - CH
city: Pierre Bénite
country: France
facility: Lyon Sud
city: Rouen
country: France
facility: Rouen - CHU
city: Saint Quentin
country: France
facility: Saint Quentin - CH
city: Saint-Etienne
country: France
facility: CHU Saint-Etienne Pneumologie
city: Strasbourg
country: France
facility: Strasbourg - NHC
city: Suresnes
country: France
facility: Suresnes - Hopital Foch
city: Thonon les bains
country: France
facility: Thonon les bains - CH
city: Toulon
country: France
facility: Toulon - CHI
city: Toulon
country: France
facility: Toulon - HIA
city: Toulouse
country: France
facility: Toulouse - CHU Larrey
city: Tours
country: France
facility: Tours - CHU
city: Valenciennes
country: France
facility: Valenciennes - Clinique
city: Villefranche
country: France
facility: CH de Villefranche - Pneumologie
city: Villejuif
country: France
facility: Institut Gustave Roussy
Study officials:
affiliation: CHRU LILLE
name: Alexis CORTOT, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Gustave Roussy, Cancer Campus, Grand Paris
name: Benjamin BESSE, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cortot AB, Audigier-Valette C, Molinier O, Le Moulec S, Barlesi F, Zalcman G, Dumont P, Pouessel D, Poulet C, Fontaine-Delaruelle C, Hiret S, Dixmier A, Renault PA, Becht C, Raffy O, Dayen C, Mazieres J, Pichon E, Langlais A, Morin F, Moro-Sibilot D, Besse B. Weekly paclitaxel plus bevacizumab versus docetaxel as second- or third-line treatment in advanced non-squamous non-small-cell lung cancer: Results of the IFCT-1103 ULTIMATE study. Eur J Cancer. 2020 May;131:27-36. doi: 10.1016/j.ejca.2020.02.022. Epub 2020 Apr 8.