Non-squamous Non-small Cell Lung Cancer
Conditions
Keywords
Lung cancer, Paclitaxel bevacizumab, IFCT
Brief summary
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.
Interventions
DRUGDocetaxel
75 mg/m² IV on day one of 21 days cycle Number of Cycles: until progression or unacceptable toxicity develops.
DRUGPaclitaxel
90 mg/m² IV on day 1, 8 and 15 of 28 days cycle Number of Cycles: until progression or unacceptable toxicity develops.
DRUGBevacizumab
10 mg/kg IV on day 1 and 15 of 28 days cycle Number of Cycles: until progression or unacceptable toxicity develops.
Sponsors
Intergroupe Francophone de Cancerologie Thoracique
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression free survival | about 4 months | Time between inclusion and progression |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Response Rate | At 8 weeks | — |
| Overall survival | about 8 months | Time between inclusion and death |
Countries
France
Outcome results
None listed