Clinical Trial: Paclitaxel + Bevacizumab (Avastin®) for the Treatment of Metastatic or Unresectable Angiosarcoma
Study Status: Active, not recruiting
Recruit Status: Unknown status
Study Type: Interventional
Official Title: Paclitaxel in Combination With Bevacizumab (Avastin®) for the Treatment of Metastatic or Unresectable Angiosarcoma
Brief Summary: This is an open-label, single-arm, multi-center, Phase 2 study with Paclitaxel in combination with Bevacizumab in patients with Unresectable or Metastatic Angiosarcoma. The study aims to determine the safety and effectiveness of combining two drugs Paclitaxel and Bevacizumab in the treatment of Angiosarcoma that cannot be removed by surgery, or has spread to other parts of your body. The primary objective is to evaluate 4month non progression rate. The secondary objective is to evaluate overall response rate after 3rd and 6th cycle, median duration of response, 6th and 12th month survival, toxicity of Paclitaxel and Bevacizumab combination, toxicity of maintenance Bevacizumab and to collect paraffin-embedded tumor blocks for angiogenesis markers and tissue microarray.
Detailed Summary:
Sponsor: Stanford University
Current Primary Outcome: Progression free survival [ Time Frame: 4 months ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Overall response rate [ Time Frame: After the 3rd and 6th cycles. ]
- Safety and overall survival [ Time Frame: At 6 months and 12 months ]
Original Secondary Outcome: Same as current
Information By: Stanford University
Dates:
Date Received: January 21, 2010
Date Started: February 2010
Date Completion: December 2014
Last Updated: June 24, 2014
Last Verified: June 2014
