Paclitaxel-bevacizumab in Advanced Lung Cancer

Sponsor
Intergroupe Francophone de Cancerologie Thoracique
Study ID
NCT01763671
Phase
PHASE3
Status
Completed

Conditions

  • Non-squamous Non-small Cell Lung Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Docetaxel — DRUG
    75 mg/m² IV on day one of 21 days cycle Number of Cycles: until progression or unacceptable toxicity develops.
  • Paclitaxel — DRUG
    90 mg/m² IV on day 1, 8 and 15 of 28 days cycle Number of Cycles: until progression or unacceptable toxicity develops.
  • Bevacizumab — DRUG
    10 mg/kg IV on day 1 and 15 of 28 days cycle Number of Cycles: until progression or unacceptable toxicity develops.

Study Details

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.

Key Dates

First listed
Jan 9, 2013
Start date
May 31, 2013
Status verified
Mar 2023
Primary completion
Dec 31, 2015
Completion
Apr 30, 2017

Study Design

Enrollment
166 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Active Comparator: Docetaxel
  • Experimental: Paclitaxel - Bevacizumab

Primary Outcome Measure

Progression free survival [ Time Frame: about 4 months ]

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