Efficacity of Paclitaxel in association or not with Bevacizumab in treatment of angiosarcoma
Randomization is stratified : * angiosarcoma in irradiated region : yes / no * visceral angiosarcoma : yes / no All patient will received a maximum of 6 cycles of weekly Paclitaxel (Arm A and B) in association or not with Bevacizumab (ArmB). 1 cycle = 28 days Treatment by Bevacizumab is to continue beyond the 6th cycle, until disease progression or unacceptable toxicity Arm A and B: Day 1, D8 and D15 Paclitaxel : 90 mg/m², IV weekly with premedication Arm B : Day 1 and D15 Bevacizumab : 10 mg/kg and then, Bevacizumab : 15 mg/kg/3 weeks until disease progression or unacceptable toxicity
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
70
Day 1, 8 and 15 : Paclitaxel 90 mg/m², IV over 1h, during 6 cycles (1 cycle = 28 days)
Bevacizumab until progression or inacceptable toxicity : * During the cycles of chemotherapy : Day 1 and D15 : 10 mg/kg,IV * After 6 cycles of chemotherapy : 15 mg/kg, IV
Institut Bergonié
Bordeaux, France
Centre François Baclesse
Caen, France
Centre Jean Perrin
Clermont-Ferrand, France
Progression free rate after 6 months of treatment
Stable disease, complete response and partial response according to RECIST 1.1
Time frame: after 6 months of treatment
Objective response at 3, 6, 9 months of treatment
Stable disease, complete response and partial response according to RECIST 1.1
Time frame: at 3, 6, 9 months of treatment
Median progression-free rate
Median time for both cohort between : * date of inclusion * date of clinical or radiological progression
Time frame: an average time period of 1 year
Global median survival
Median time for both cohort between : * date of inclusion * date of death whatever the cause
Time frame: an average time period of 18 months
Tolerance
According to NCI-CTCAE v4.0
Time frame: during the study
Correlation between efficacity and serum expression of anti angiogenic factors
Blood samples at different times
Time frame: Day 1, 8, 15, 29 and 57
Correlation between efficacity and beta-tubuline III expression in tissue
Paraffin blocks
Time frame: At baseline
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Centre Georges François Leclerc
Dijon, France
Centre Oscar Lambret
Lille, France
Centre Léon Bérard
Lyon, France
Centre Val d'Aurelle
Montpellier, France
Centre Antoine Lacassagne
Nice, France
Institut Curie
Paris, France
Centre René Gauducheau
Saint-Herblain, France
...and 3 more locations