NCT01303497

Efficacity of Weekly Paclitaxel in Association or Not With Bevacizumab in Metastatic or Locally Advanced Angiosarcomas

Phase II Study, Multicenter, Randomized, Stratified, Evaluating the Efficacity of Weekly Paclitaxel, With or Without Bevacizumab in the Treatment of Metastatic or Locally Advanced Angiosarcomas Not Accessible to Surgery Treatment.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 70 (estimated)
• Sponsor: Centre Oscar Lambret · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Efficacity of Paclitaxel in association or not with Bevacizumab in treatment of angiosarcoma

Detailed description

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

Conditions

• Angiosarcoma

Interventions

Type	Name	Description
DRUG	Paclitaxel	Day 1, 8 and 15 : Paclitaxel 90 mg/m², IV over 1h, during 6 cycles (1 cycle = 28 days)
DRUG	Bevacizumab	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

Timeline

• Start date: 2010-09-10
• Primary completion: 2014-04-01
• Completion: 2019-01-29
• First posted: 2011-02-24
• Last updated: 2026-03-13

Locations

13 sites across 1 country: France