Paclitaxel-bevacizumab in Advanced Lung Cancer
Ultimate
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
1 other identifier
interventional
166
1 country
55
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started May 2013
Typical duration for phase_3
55 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 7, 2013
CompletedFirst Posted
Study publicly available on registry
January 9, 2013
CompletedStudy Start
First participant enrolled
May 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2017
CompletedMarch 14, 2023
March 1, 2023
2.6 years
January 7, 2013
March 10, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression free survival
Time between inclusion and progression
about 4 months
Secondary Outcomes (2)
Response Rate
At 8 weeks
Overall survival
about 8 months
Study Arms (2)
Docetaxel
ACTIVE COMPARATORPaclitaxel - Bevacizumab
EXPERIMENTALInterventions
75 mg/m² IV on day one of 21 days cycle Number of Cycles: until progression or unacceptable toxicity develops.
90 mg/m² IV on day 1, 8 and 15 of 28 days cycle Number of Cycles: until progression or unacceptable toxicity develops.
10 mg/kg IV on day 1 and 15 of 28 days cycle Number of Cycles: until progression or unacceptable toxicity develops.
Eligibility Criteria
You may qualify if:
- nd or 3rd line of non squamous non small cell lung cancer of stage III or IV
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (55)
Amiens - CHU
Amiens, France
Centre Hospitalier
Annemasse, France
Hôpital Privé d'Antony
Antony, France
Avignon - Institut Sainte-Catherine
Avignon, 84918, France
CH de la Côte Basque
Bayonne, France
Béziers - CH
Béziers, 34525, France
Bordeaux - Polyclinique Nord
Bordeaux, 33300, France
Caen - Centre François Baclesse
Caen, 14000, France
Caen - CHU Côte de Nacre
Caen, 14000, France
Castelnau Le Lez - Clinique
Castelnau, 34170, France
CH de Chartres Hôpital Louis Pasteur
Chartres, France
Chauny - CH
Chauny, France
CH
Cholet, France
Hôpital Percy-Armées - Pneumologie
Clamart, 92140, 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, 76700, France
CH Région Saint-Omer
Helfaut, France
Le Mans - Centre Hospitalier
Le Mans, 72000, France
CHU (Hôpital Calmette) - Pneumologie
Lille, 59000, 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, 78200, France
Marseille - Hôpital Sainte Marguerite
Marseille, 13000, France
Maubeuge - Polyclinique du Parc
Maubeuge, 59600, France
CH de Macon
Mâcon, France
CH Montélimar
Montélimar, France
Mulhouse - CH
Mulhouse, 68000, France
Nantes - Centre René Gauducheau
Nantes, 44805, France
CHR d'Orléans La Source
Orléans, France
Paris - Saint Louis
Paris, 75000, France
Hopital Tenon - Pneumologie
Paris, 75020, France
HIA Val-de-Grâce
Paris, France
Hôpital Bichat - Claude - Bernard
Paris, France
Paris - Pitié-salpêtrière
Paris, France
Pau - CH
Pau, 64046, France
Lyon Sud
Pierre-Bénite, 69495, France
Rouen - CHU
Rouen, 76000, France
CHU Saint-Etienne Pneumologie
Saint-Etienne, 42000, France
Saint Quentin - CH
Saint-Quentin, 02100, France
Strasbourg - NHC
Strasbourg, 63000, France
Suresnes - Hopital Foch
Suresnes, 92151, France
Thonon les bains - CH
Thonon-les-Bains, 74200, France
Toulon - CHI
Toulon, 83000, France
Toulon - HIA
Toulon, 83000, France
Toulouse - CHU Larrey
Toulouse, France
Tours - CHU
Tours, 37000, France
Valenciennes - Clinique
Valenciennes, 59304, France
CH de Villefranche - Pneumologie
Villefranche, France
Institut Gustave Roussy
Villejuif, 94800, France
Related Publications (1)
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.
PMID: 32276179DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Alexis CORTOT, MD
CHRU LILLE
- PRINCIPAL INVESTIGATOR
Benjamin BESSE, MD
Gustave Roussy, Cancer Campus, Grand Paris
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 7, 2013
First Posted
January 9, 2013
Study Start
May 1, 2013
Primary Completion
December 1, 2015
Study Completion
April 1, 2017
Last Updated
March 14, 2023
Record last verified: 2023-03