Clinical Trial: Efficacity of Weekly Paclitaxel in Association or Not With Bevacizumab in Metastatic or Locally Advanced Angiosarcomas
Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional
Official Title: Phase II Study, Multicenter, Randomized, Stratified, Evaluating the Efficacity of Weekly Paclitaxel, With or Without Bevacizumab in the Treatment of Metastatic or Locally Advanced 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
Sponsor: Centre Oscar Lambret
Current Primary Outcome: Progression free rate after 6 months of treatment [ Time Frame: after 6 months of treatment ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Objective response at 3, 6, 9 months of treatment [ Time Frame: at 3, 6, 9 months of treatment ]Stable disease, complete response and partial response according to RECIST 1.1
- Median progression-free rate [ Time Frame: an average time period of 1 year ]
Median time for both cohort between :
- date of inclusion
- date of clinical or radiological progression
- Global median survival [ Time Frame: an average time period of 18 months ]
Median time for both cohort between :
- date of inclusion
- date of death whatever the cause
- Tolerance [ Time Frame: during the study ]According to NCI-CTCAE v4.0
- Correlation between efficacity and serum expression of anti angiogenic factors [ Time Frame: Day 1, 8, 15, 29 and 57 ]Blood samples at different times
- Correlation between efficacity and beta-tubuline III expression in tissue [ Time Frame: At baseline ]Paraffin blocks
Original Secondary Outcome:
- Objective response at 3, 6, 9 months of treatment [ Time Frame: at 3, 6, 9 months of treatment ]Stable disease, complete response and partial response according to RECIST 1.1
- Median progression-free rate [ Time Frame: Until disease progression ]
Median time for both cohort between :
- date of inclusion
- date of clinical or radiological progression
- Global median survival [ Time Frame: until death ]
Median time for both cohort between :
- date of inclusion
- date of death wathever the cause
- Tolerance [ Time Frame: Troughout the study ]According to NCI-CTCAE v4.0
- Correlation between efficacity and serum expression of anti angiogenic factors [ Time Frame: Day 1, 8, 15, 29 and 57 ]Blood samples at different times
- Correlation between efficacity and beta-tubuline III expression in tissue [ Time Frame: At baseline ]Paraffin blocks
Information By: Centre Oscar Lambret
Dates:
Date Received: February 23, 2011
Date Started: September 2010
Date Completion: June 2017
Last Updated: January 11, 2017
Last Verified: January 2017