Paclitaxel-bevacizumab in Advanced Lung Cancer

Non-squamous Non-small Cell Lung Cancer Clinical Trial

— Ultimate  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01763671
• Other study ID #: IFCT-1103
• Status: Completed
• Phase: Phase 3
• Start date: May 2013
• Est. completion date: April 2017

Study information

• Verified date: March 2023
• Source: Intergroupe Francophone de Cancerologie Thoracique
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 166
• Est. completion date: April 2017
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-squamous Non-small Cell Lung Cancer

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
France	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	CH de Macon	Macon
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	Mulhouse - CH	Mulhouse
France	Nantes - Centre René Gauducheau	Nantes
France	CHR d'Orléans La Source	Orléans
France	HIA Val-de-Grâce	Paris
France	Hôpital Bichat - Claude - Bernard	Paris
France	Hopital Tenon - Pneumologie	Paris
France	Paris - Pitié-salpêtrière	Paris
France	Paris - Saint Louis	Paris
France	Pau - CH	Pau
France	Lyon Sud	Pierre Bénite
France	Rouen - CHU	Rouen
France	Saint Quentin - CH	Saint Quentin
France	CHU Saint-Etienne Pneumologie	Saint-Etienne
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

Sponsors (1)

Lead Sponsor	Collaborator
Intergroupe Francophone de Cancerologie Thoracique

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression free survival	Time between inclusion and progression	about 4 months
Secondary	Response Rate		At 8 weeks
Secondary	Overall survival	Time between inclusion and death	about 8 months

External Links

•   Official IFCT website