Ignite Creation Date:
2024-05-05 @ 11:19 PM
Last Modification Date:
2024-10-26 @ 10:32 AM
Study NCT ID:
NCT01303497
Status:
COMPLETED
Last Update Posted:
2019-05-30
First Post:
2011-02-23
Brief Title:
Efficacity of Weekly Paclitaxel in Association or Not With Bevacizumab in Metastatic or Locally Advanced Angiosarcomas
Sponsor:
Centre Oscar Lambret
Organization:
Centre Oscar Lambret
Study Overview
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 Angiosarcomas Not Accessible to Surgery Treatment
Status:
COMPLETED
Status Verified Date:
2017-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ANGIO-TAX
Brief 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 mgm² IV weekly with premedication
Arm B
Day 1 and D15 Bevacizumab 10 mgkg and then Bevacizumab 15 mgkg3 weeks until disease progression or unacceptable toxicity
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 mgm² IV weekly with premedication
Arm B
Day 1 and D15 Bevacizumab 10 mgkg and then Bevacizumab 15 mgkg3 weeks until disease progression or unacceptable toxicity
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None