Paclitaxel-bevacizumab in Advanced Lung Cancer

Phase 3

Completed

• Conditions: Non-squamous Non-small Cell Lung Cancer
• Interventions: Drug: Docetaxel; Drug: Paclitaxel; Drug: Bevacizumab

• Registration Number: NCT01763671
• Lead Sponsor: Intergroupe Francophone de Cancerologie Thoracique

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-01-07
• Study First Submitted QC: 2013-01-08
• Study First Posted: 2013-01-09
• Study Start: 2013-05
• Primary Completion: 2015-12
• Study Completion: 2017-04
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-10
• Last Update Posted: 2023-03-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 166

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Docetaxel	Docetaxel	-
Paclitaxel - Bevacizumab	Paclitaxel	-
Paclitaxel - Bevacizumab	Bevacizumab	-

Primary Outcome Measures

Name	Time	Method
Progression free survival	about 4 months	Time between inclusion and progression

Secondary Outcome Measures

Name	Time	Method
Response Rate	At 8 weeks
Overall survival	about 8 months	Time between inclusion and death

Trial Locations

Locations (54)

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

Bordeaux - Polyclinique Nord; 🇫🇷 Bordeaux, France

Béziers - CH; 🇫🇷 Béziers, France

Caen - Centre François Baclesse; 🇫🇷 Caen, France

Caen - CHU Côte de Nacre; 🇫🇷 Caen, France

Castelnau Le Lez - Clinique; 🇫🇷 Castelnau, France

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