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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Docetaxel | Active Comparator |
| |
| Paclitaxel - Bevacizumab | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Docetaxel | Drug | 75 mg/m² IV on day one of 21 days cycle Number of Cycles: until progression or unacceptable toxicity develops. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression free survival | Time between inclusion and progression | about 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| Response Rate | At 8 weeks | |
| Overall survival | Time between inclusion and death | about 8 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alexis CORTOT, MD | CHRU LILLE | Principal Investigator |
| Benjamin BESSE, MD | Gustave Roussy, Cancer Campus, Grand Paris | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Amiens - CHU | Amiens | France | ||||
| Centre Hospitalier |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32276179 | Derived | 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. |
| Label | URL |
|---|---|
| Official IFCT website | View source |
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| Paclitaxel | Drug | 90 mg/m² IV on day 1, 8 and 15 of 28 days cycle Number of Cycles: until progression or unacceptable toxicity develops. |
|
| Bevacizumab | Drug | 10 mg/kg IV on day 1 and 15 of 28 days cycle Number of Cycles: until progression or unacceptable toxicity develops. |
|
| 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 |
| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D000077143 | Docetaxel |
| D017239 | Paclitaxel |
| D000068258 | Bevacizumab |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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