Paclitaxel-bevacizumab in Advanced Lung Cancer

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Non-squamous Non-small Cell Lung Cancer

Intervention / Treatment
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* Drug: Docetaxel
* Drug: Paclitaxel
* Drug: Bevacizumab


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Docetaxel<br> | Drug: Docetaxel<br>* 75 mg/m² IV on day one of 21 days cycle Number of Cycles: until progression or unacceptable toxicity develops.<br>|
| Experimental: Paclitaxel - Bevacizumab<br> | Drug: Paclitaxel<br>* 90 mg/m² IV on day 1, 8 and 15 of 28 days cycle Number of Cycles: until progression or unacceptable toxicity develops.<br>Drug: Bevacizumab<br>* 10 mg/kg IV on day 1 and 15 of 28 days cycle Number of Cycles: until progression or unacceptable toxicity develops.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression free survival | Time between inclusion and progression | about 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response Rate |  | At 8 weeks | 
| Overall survival | Time between inclusion and death | about 8 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lung cancer, Paclitaxel bevacizumab, IFCT