Paclitaxel-bevacizumab in Advanced Lung Cancer (Ultimate)

March 10, 2023 updated by: Intergroupe Francophone de Cancerologie Thoracique

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

166

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Amiens, France
        • Amiens - CHU
      • Annemasse, France
        • Centre Hospitalier
      • Antony, France
        • Hôpital Privé d'Antony
      • Avignon, France, 84918
        • Avignon - Institut Sainte-Catherine
      • Bayonne, France
        • CH de la Côte Basque
      • Bordeaux, France, 33300
        • Bordeaux - Polyclinique Nord
      • Béziers, France, 34525
        • Béziers - CH
      • Caen, France, 14000
        • Caen - Centre François Baclesse
      • Caen, France, 14000
        • Caen - CHU Côte de Nacre
      • Castelnau, France, 34170
        • Castelnau Le Lez - Clinique
      • Chartres, France
        • CH de Chartres Hôpital Louis Pasteur
      • Chauny, France
        • Chauny - CH
      • Cholet, France
        • CH
      • Clamart, France, 92140
        • Hôpital Percy-Armées - Pneumologie
      • Clermont-Ferrand, France
        • Hôpitral Gabriel Montpied - Pneumologie
      • Colmar, France
        • CH
      • Compiègne, France
        • CH Compiègne - Pneumologie
      • Créteil, France
        • Chi Creteil
      • Grenoble, France
        • CHRU Grenoble
      • Harfleur, France, 76700
        • Harfleur - Clinique du Petit Colmoulins
      • Helfaut, France
        • CH Région Saint-Omer
      • Le Mans, France, 72000
        • Le Mans - Centre Hospitalier
      • Lille, France, 59000
        • CHU (Hôpital Calmette) - Pneumologie
      • Longjumeau, France
        • CH de Longjumeau
      • Lorient, France
        • Lorient - CHBS
      • Lyon, France
        • Lyon - Hôpital Jean Mermoz
      • Lyon, France
        • Lyon - Hôpital Louis Pradel (Pneumologie)
      • Macon, France
        • CH de Macon
      • Mantes La Jolie, France, 78200
        • Mantes La Jolie - CH
      • Marseille, France, 13000
        • Marseille - Hôpital Sainte Marguerite
      • Maubeuge, France, 59600
        • Maubeuge - Polyclinique du Parc
      • Montélimar, France
        • CH Montélimar
      • Mulhouse, France, 68000
        • Mulhouse - CH
      • Nantes, France, 44805
        • Nantes - Centre René Gauducheau
      • Orléans, France
        • CHR d'Orléans La Source
      • Paris, France, 75000
        • Paris - Saint Louis
      • Paris, France, 75020
        • Hopital Tenon - Pneumologie
      • Paris, France
        • HIA Val-de-Grâce
      • Paris, France
        • Hôpital Bichat - Claude - Bernard
      • Paris, France
        • Paris - Pitié-Salpêtrière
      • Pau, France, 64046
        • Pau - CH
      • Pierre Bénite, France, 69495
        • Lyon Sud
      • Rouen, France, 76000
        • Rouen - CHU
      • Saint Quentin, France, 02100
        • Saint Quentin - CH
      • Saint-Etienne, France, 42000
        • CHU Saint-Etienne Pneumologie
      • Strasbourg, France, 63000
        • Strasbourg - NHC
      • Suresnes, France, 92151
        • Suresnes - Hopital Foch
      • Thonon les bains, France, 74200
        • Thonon les bains - CH
      • Toulon, France, 83000
        • Toulon - CHI
      • Toulon, France, 83000
        • Toulon - HIA
      • Toulouse, France
        • Toulouse - CHU Larrey
      • Tours, France, 37000
        • Tours - CHU
      • Valenciennes, France, 59304
        • Valenciennes - Clinique
      • Villefranche, France
        • CH de Villefranche - Pneumologie
      • Villejuif, France, 94800
        • Institut Gustave Roussy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Docetaxel
Drug: Docetaxel
75 mg/m² IV on day one of 21 days cycle Number of Cycles: until progression or unacceptable toxicity develops.
Experimental: Paclitaxel - Bevacizumab
Drug: Paclitaxel
90 mg/m² IV on day 1, 8 and 15 of 28 days cycle Number of Cycles: until progression or unacceptable toxicity develops.
Drug: Bevacizumab
10 mg/kg IV on day 1 and 15 of 28 days cycle Number of Cycles: until progression or unacceptable toxicity develops.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression free survival
Time Frame: about 4 months
Time between inclusion and progression
about 4 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Response Rate
Time Frame: At 8 weeks
At 8 weeks
Overall survival
Time Frame: about 8 months
Time between inclusion and death
about 8 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Intergroupe Francophone de Cancerologie Thoracique

Investigators

  • Principal Investigator: Alexis CORTOT, MD, CHRU Lille

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2013

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

April 1, 2017

Study Registration Dates

First Submitted

January 7, 2013

First Submitted That Met QC Criteria

January 8, 2013

First Posted (Estimate)

January 9, 2013

Study Record Updates

Last Update Posted (Actual)

March 14, 2023

Last Update Submitted That Met QC Criteria

March 10, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IFCT-1103

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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