Paclitaxel-bevacizumab in Advanced Lung Cancer (Ultimate)
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.
Non Squamous Non Small Cell Lung Cancer
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
|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|
- Progression free survival [ Time Frame: about 4 months ] [ Designated as safety issue: No ]Time between inclusion and progression
- Response Rate [ Time Frame: At 8 weeks ] [ Designated as safety issue: No ]
- Overall survival [ Time Frame: about 8 months ] [ Designated as safety issue: No ]Time between inclusion and death
|Study Start Date:||May 2013|
|Estimated Study Completion Date:||June 2015|
|Estimated Primary Completion Date:||March 2015 (Final data collection date for primary outcome measure)|
|Active Comparator: Docetaxel||
75 mg/m² IV on day one of 21 days cycle Number of Cycles: until progression or unacceptable toxicity develops.
|Experimental: Paclitaxel - Bevacizumab||
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.
Show 55 Study Locations
|Principal Investigator:||Alexis CORTOT, MD||CHRU Lille|
|Principal Investigator:||Benjamin BESSE, MD||Institut Gustave Roussy - Villejuif|