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Paclitaxel-bevacizumab in Advanced Lung Cancer (Ultimate)

Primary Purpose

Non-squamous Non-small Cell Lung Cancer

Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Docetaxel
Paclitaxel
Bevacizumab
Sponsored by
Intergroupe Francophone de Cancerologie Thoracique
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-squamous Non-small Cell Lung Cancer focused on measuring Lung cancer, Paclitaxel bevacizumab, IFCT

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Amiens - CHU
  • Centre Hospitalier
  • Hôpital Privé d'Antony
  • Avignon - Institut Sainte-Catherine
  • CH de la Côte Basque
  • Bordeaux - Polyclinique Nord
  • Béziers - CH
  • Caen - Centre François Baclesse
  • Caen - CHU Côte de Nacre
  • Castelnau Le Lez - Clinique
  • CH de Chartres Hôpital Louis Pasteur
  • Chauny - CH
  • CH
  • Hôpital Percy-Armées - Pneumologie
  • Hôpitral Gabriel Montpied - Pneumologie
  • CH
  • CH Compiègne - Pneumologie
  • CHI Créteil
  • CHRU Grenoble
  • Harfleur - Clinique du Petit Colmoulins
  • CH Région Saint-Omer
  • Le Mans - Centre Hospitalier
  • CHU (Hôpital Calmette) - Pneumologie
  • CH de Longjumeau
  • Lorient - CHBS
  • Lyon - Hôpital Jean Mermoz
  • Lyon - Hôpital Louis Pradel (Pneumologie)
  • CH de Macon
  • Mantes La Jolie - CH
  • Marseille - Hôpital Sainte Marguerite
  • Maubeuge - Polyclinique du Parc
  • CH Montélimar
  • Mulhouse - CH
  • Nantes - Centre René Gauducheau
  • CHR d'Orléans La Source
  • Paris - Saint Louis
  • Hopital Tenon - Pneumologie
  • HIA Val-de-Grâce
  • Hôpital Bichat - Claude - Bernard
  • Paris - Pitié-salpêtrière
  • Pau - CH
  • Lyon Sud
  • Rouen - CHU
  • Saint Quentin - CH
  • CHU Saint-Etienne Pneumologie
  • Strasbourg - NHC
  • Suresnes - Hopital Foch
  • Thonon les bains - CH
  • Toulon - CHI
  • Toulon - HIA
  • Toulouse - CHU Larrey
  • Tours - CHU
  • Valenciennes - Clinique
  • CH de Villefranche - Pneumologie
  • Institut Gustave Roussy

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Docetaxel

Paclitaxel - Bevacizumab

Arm Description

Outcomes

Primary Outcome Measures

Progression free survival
Time between inclusion and progression

Secondary Outcome Measures

Response Rate
Overall survival
Time between inclusion and death

Full Information

First Posted
January 7, 2013
Last Updated
March 10, 2023
Sponsor
Intergroupe Francophone de Cancerologie Thoracique
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1. Study Identification

Unique Protocol Identification Number
NCT01763671
Brief Title
Paclitaxel-bevacizumab in Advanced Lung Cancer
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
May 2013 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
April 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Intergroupe Francophone de Cancerologie Thoracique

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-squamous Non-small Cell Lung Cancer
Keywords
Lung cancer, Paclitaxel bevacizumab, IFCT

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
166 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Docetaxel
Arm Type
Active Comparator
Arm Title
Paclitaxel - Bevacizumab
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Docetaxel
Intervention Description
75 mg/m² IV on day one of 21 days cycle Number of Cycles: until progression or unacceptable toxicity develops.
Intervention Type
Drug
Intervention Name(s)
Paclitaxel
Intervention Description
90 mg/m² IV on day 1, 8 and 15 of 28 days cycle Number of Cycles: until progression or unacceptable toxicity develops.
Intervention Type
Drug
Intervention Name(s)
Bevacizumab
Intervention Description
10 mg/kg IV on day 1 and 15 of 28 days cycle Number of Cycles: until progression or unacceptable toxicity develops.
Primary Outcome Measure Information:
Title
Progression free survival
Description
Time between inclusion and progression
Time Frame
about 4 months
Secondary Outcome Measure Information:
Title
Response Rate
Time Frame
At 8 weeks
Title
Overall survival
Description
Time between inclusion and death
Time Frame
about 8 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexis CORTOT, MD
Organizational Affiliation
CHRU Lille
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Benjamin BESSE, MD
Organizational Affiliation
Gustave Roussy, Cancer Campus, Grand Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Amiens - CHU
City
Amiens
Country
France
Facility Name
Centre Hospitalier
City
Annemasse
Country
France
Facility Name
Hôpital Privé d'Antony
City
Antony
Country
France
Facility Name
Avignon - Institut Sainte-Catherine
City
Avignon
ZIP/Postal Code
84918
Country
France
Facility Name
CH de la Côte Basque
City
Bayonne
Country
France
Facility Name
Bordeaux - Polyclinique Nord
City
Bordeaux
ZIP/Postal Code
33300
Country
France
Facility Name
Béziers - CH
City
Béziers
ZIP/Postal Code
34525
Country
France
Facility Name
Caen - Centre François Baclesse
City
Caen
ZIP/Postal Code
14000
Country
France
Facility Name
Caen - CHU Côte de Nacre
City
Caen
ZIP/Postal Code
14000
Country
France
Facility Name
Castelnau Le Lez - Clinique
City
Castelnau
ZIP/Postal Code
34170
Country
France
Facility Name
CH de Chartres Hôpital Louis Pasteur
City
Chartres
Country
France
Facility Name
Chauny - CH
City
Chauny
Country
France
Facility Name
CH
City
Cholet
Country
France
Facility Name
Hôpital Percy-Armées - Pneumologie
City
Clamart
ZIP/Postal Code
92140
Country
France
Facility Name
Hôpitral Gabriel Montpied - Pneumologie
City
Clermont-Ferrand
Country
France
Facility Name
CH
City
Colmar
Country
France
Facility Name
CH Compiègne - Pneumologie
City
Compiègne
Country
France
Facility Name
CHI Créteil
City
Créteil
Country
France
Facility Name
CHRU Grenoble
City
Grenoble
Country
France
Facility Name
Harfleur - Clinique du Petit Colmoulins
City
Harfleur
ZIP/Postal Code
76700
Country
France
Facility Name
CH Région Saint-Omer
City
Helfaut
Country
France
Facility Name
Le Mans - Centre Hospitalier
City
Le Mans
ZIP/Postal Code
72000
Country
France
Facility Name
CHU (Hôpital Calmette) - Pneumologie
City
Lille
ZIP/Postal Code
59000
Country
France
Facility Name
CH de Longjumeau
City
Longjumeau
Country
France
Facility Name
Lorient - CHBS
City
Lorient
Country
France
Facility Name
Lyon - Hôpital Jean Mermoz
City
Lyon
Country
France
Facility Name
Lyon - Hôpital Louis Pradel (Pneumologie)
City
Lyon
Country
France
Facility Name
CH de Macon
City
Macon
Country
France
Facility Name
Mantes La Jolie - CH
City
Mantes La Jolie
ZIP/Postal Code
78200
Country
France
Facility Name
Marseille - Hôpital Sainte Marguerite
City
Marseille
ZIP/Postal Code
13000
Country
France
Facility Name
Maubeuge - Polyclinique du Parc
City
Maubeuge
ZIP/Postal Code
59600
Country
France
Facility Name
CH Montélimar
City
Montélimar
Country
France
Facility Name
Mulhouse - CH
City
Mulhouse
ZIP/Postal Code
68000
Country
France
Facility Name
Nantes - Centre René Gauducheau
City
Nantes
ZIP/Postal Code
44805
Country
France
Facility Name
CHR d'Orléans La Source
City
Orléans
Country
France
Facility Name
Paris - Saint Louis
City
Paris
ZIP/Postal Code
75000
Country
France
Facility Name
Hopital Tenon - Pneumologie
City
Paris
ZIP/Postal Code
75020
Country
France
Facility Name
HIA Val-de-Grâce
City
Paris
Country
France
Facility Name
Hôpital Bichat - Claude - Bernard
City
Paris
Country
France
Facility Name
Paris - Pitié-salpêtrière
City
Paris
Country
France
Facility Name
Pau - CH
City
Pau
ZIP/Postal Code
64046
Country
France
Facility Name
Lyon Sud
City
Pierre Bénite
ZIP/Postal Code
69495
Country
France
Facility Name
Rouen - CHU
City
Rouen
ZIP/Postal Code
76000
Country
France
Facility Name
Saint Quentin - CH
City
Saint Quentin
ZIP/Postal Code
02100
Country
France
Facility Name
CHU Saint-Etienne Pneumologie
City
Saint-Etienne
ZIP/Postal Code
42000
Country
France
Facility Name
Strasbourg - NHC
City
Strasbourg
ZIP/Postal Code
63000
Country
France
Facility Name
Suresnes - Hopital Foch
City
Suresnes
ZIP/Postal Code
92151
Country
France
Facility Name
Thonon les bains - CH
City
Thonon les bains
ZIP/Postal Code
74200
Country
France
Facility Name
Toulon - CHI
City
Toulon
ZIP/Postal Code
83000
Country
France
Facility Name
Toulon - HIA
City
Toulon
ZIP/Postal Code
83000
Country
France
Facility Name
Toulouse - CHU Larrey
City
Toulouse
Country
France
Facility Name
Tours - CHU
City
Tours
ZIP/Postal Code
37000
Country
France
Facility Name
Valenciennes - Clinique
City
Valenciennes
ZIP/Postal Code
59304
Country
France
Facility Name
CH de Villefranche - Pneumologie
City
Villefranche
Country
France
Facility Name
Institut Gustave Roussy
City
Villejuif
ZIP/Postal Code
94800
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
32276179
Citation
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.
Results Reference
derived
Links:
URL
https://www.ifct.fr/etudes-cliniques/420-ifct-1103
Description
Official IFCT website

Learn more about this trial

Paclitaxel-bevacizumab in Advanced Lung Cancer

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