Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
166 participants
INTERVENTIONAL
2013-05-31
2017-04-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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Docetaxel
Docetaxel
75 mg/m² IV on day one of 21 days cycle Number of Cycles: until progression or unacceptable toxicity develops.
Paclitaxel - Bevacizumab
Paclitaxel
90 mg/m² IV on day 1, 8 and 15 of 28 days cycle Number of Cycles: until progression or unacceptable toxicity develops.
Bevacizumab
10 mg/kg IV on day 1 and 15 of 28 days cycle Number of Cycles: until progression or unacceptable toxicity develops.
Interventions
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Docetaxel
75 mg/m² IV on day one of 21 days cycle Number of Cycles: until progression or unacceptable toxicity develops.
Paclitaxel
90 mg/m² IV on day 1, 8 and 15 of 28 days cycle Number of Cycles: until progression or unacceptable toxicity develops.
Bevacizumab
10 mg/kg IV on day 1 and 15 of 28 days cycle Number of Cycles: until progression or unacceptable toxicity develops.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Intergroupe Francophone de Cancerologie Thoracique
OTHER
Responsible Party
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Principal Investigators
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Alexis CORTOT, MD
Role: PRINCIPAL_INVESTIGATOR
CHRU LILLE
Benjamin BESSE, MD
Role: PRINCIPAL_INVESTIGATOR
Gustave Roussy, Cancer Campus, Grand Paris
Locations
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Amiens - CHU
Amiens, , France
Centre Hospitalier
Annemasse, , France
Hôpital Privé d'Antony
Antony, , France
Avignon - Institut Sainte-Catherine
Avignon, , France
CH de la Côte Basque
Bayonne, , France
Béziers - CH
Béziers, , France
Bordeaux - Polyclinique Nord
Bordeaux, , France
Caen - Centre François Baclesse
Caen, , France
Caen - CHU Côte de Nacre
Caen, , France
Castelnau Le Lez - Clinique
Castelnau, , France
CH de Chartres Hôpital Louis Pasteur
Chartres, , France
Chauny - CH
Chauny, , France
CH
Cholet, , France
Hôpital Percy-Armées - Pneumologie
Clamart, , France
Hôpitral Gabriel Montpied - Pneumologie
Clermont-Ferrand, , France
CH
Colmar, , France
CH Compiègne - Pneumologie
Compiègne, , France
CHI Créteil
Créteil, , France
CHRU Grenoble
Grenoble, , France
Harfleur - Clinique du Petit Colmoulins
Harfleur, , France
CH Région Saint-Omer
Helfaut, , France
Le Mans - Centre Hospitalier
Le Mans, , France
CHU (Hôpital Calmette) - Pneumologie
Lille, , France
CH de Longjumeau
Longjumeau, , France
Lorient - CHBS
Lorient, , France
Lyon - Hôpital Jean Mermoz
Lyon, , France
Lyon - Hôpital Louis Pradel (Pneumologie)
Lyon, , France
Mantes La Jolie - CH
Mantes-la-Jolie, , France
Marseille - Hôpital Sainte Marguerite
Marseille, , France
Maubeuge - Polyclinique du Parc
Maubeuge, , France
CH de Macon
Mâcon, , France
CH Montélimar
Montélimar, , France
Mulhouse - CH
Mulhouse, , France
Nantes - Centre René Gauducheau
Nantes, , France
CHR d'Orléans La Source
Orléans, , France
Paris - Saint Louis
Paris, , France
Hopital Tenon - Pneumologie
Paris, , France
HIA Val-de-Grâce
Paris, , France
Hôpital Bichat - Claude - Bernard
Paris, , France
Paris - Pitié-salpêtrière
Paris, , France
Pau - CH
Pau, , France
Lyon Sud
Pierre-Bénite, , France
Rouen - CHU
Rouen, , France
CHU Saint-Etienne Pneumologie
Saint-Etienne, , France
Saint Quentin - CH
Saint-Quentin, , France
Strasbourg - NHC
Strasbourg, , France
Suresnes - Hopital Foch
Suresnes, , France
Thonon les bains - CH
Thonon-les-Bains, , France
Toulon - CHI
Toulon, , France
Toulon - HIA
Toulon, , 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
Countries
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References
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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.
Related Links
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Official IFCT website
Other Identifiers
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IFCT-1103
Identifier Type: -
Identifier Source: org_study_id
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