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

Sponsor
Centre Oscar Lambret
Study ID
NCT01303497
Phase
PHASE2
Status
Completed

Conditions

  • Angiosarcoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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

Key Dates

First listed
Feb 24, 2011
Start date
Sep 10, 2010
Status verified
Mar 2026
Primary completion
Apr 30, 2014
Completion
Jan 29, 2019

Study Design

Enrollment
70 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Other: Arm A : Paclitaxel
    administration of paclitaxel drug during cycle of 28 days (6 cycles Max) + blood sample on day 1, 8, 15, 29 and 57
  • Other: Arm B : Paclitaxel + Bevacizumab
    administration of paclitaxel drug during per cycle of 28 days (6 cycles Max) + Bevacizumab every two weeks during paclitaxel cycles then every 3 weeks during P cycles until disease progression or inacceptable toxicity \+ blood sample on day 1, 8, 15, 29 and 57

Primary Outcome Measure

Progression free rate after 6 months of treatment [ Time Frame: after 6 months of treatment ]

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