Paclitaxel-bevacizumab in Advanced Lung Cancer (Ultimate)
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|ClinicalTrials.gov Identifier: NCT01763671|
Recruitment Status : Completed
First Posted : January 9, 2013
Last Update Posted : September 20, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Non-squamous Non-small Cell Lung Cancer||Drug: Docetaxel Drug: Paclitaxel Drug: Bevacizumab||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||164 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|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 Start Date :||May 2013|
|Actual Primary Completion Date :||December 2015|
|Actual Study Completion Date :||April 2017|
|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.
10 mg/kg IV on day 1 and 15 of 28 days cycle Number of Cycles: until progression or unacceptable toxicity develops.
- Progression free survival [ Time Frame: about 4 months ]Time between inclusion and progression
- Response Rate [ Time Frame: At 8 weeks ]
- Overall survival [ Time Frame: about 8 months ]Time between inclusion and death
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01763671
|Principal Investigator:||Alexis CORTOT, MD||CHRU Lille|
|Principal Investigator:||Benjamin BESSE, MD||Gustave Roussy, Cancer Campus, Grand Paris|