Paclitaxel-bevacizumab in Advanced Lung Cancer (Ultimate)

I

Intergroupe Francophone de Cancerologie Thoracique

Status and phase

Completed
Phase 3

Conditions

Non-squamous Non-small Cell Lung Cancer

Treatments

Drug: Bevacizumab
Drug: Docetaxel
Drug: Paclitaxel

Study type

Interventional

Funder types

Other

Identifiers

NCT01763671
IFCT-1103

Details and patient eligibility

About

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.

Enrollment

166 patients

Sex

All

Ages

18+ years old

Volunteers

No 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

166 participants in 2 patient groups

Docetaxel
Active Comparator group
Treatment:
Drug: Docetaxel
Paclitaxel - Bevacizumab
Experimental group
Treatment:
Drug: Paclitaxel
Drug: Bevacizumab

Trial contacts and locations

55

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Data sourced from clinicaltrials.gov

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