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 ]

Stable disease, complete response and partial response according to RECIST 1.1


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