NCT01055028

Paclitaxel + Bevacizumab (Avastin) for the Treatment of Metastatic or Unresectable Angiosarcoma

Paclitaxel in Combination With Bevacizumab (Avastin) for the Treatment of Metastatic or Unresectable Angiosarcoma

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Stanford University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 description

Regimen A versus B was chosen at the discretion of the treating physician. Both groups were analyzed together as far as outcome. Patients were to receive paclitaxel 200 mg/m2 intravenously over 3 hours every 21 days (Regimen A) or pactlitaxel 90 mg/m2 weekly x 3 of a 28 day cycle (Regimen B) followed by bevacizumab 15 mg/kg intravenously over (cycle 1: 90 min; cycle 2: 60 min; cycles 3-6: 30 min) every 21 days x 6 cycles. Maintenance bevacizumab (MB) started after the completion of combination of paclitaxel and bevacizumab and it was given at a dose of 15 mg/kg intravenously once every 21 days for a maximum of 8 cycles. Patients were allowed to receive growth factors. Dose reductions were done based on hematologic and non-hematologic toxicities.

Conditions

• Angiosarcomas
• Soft Tissue Sarcoma

Interventions

Type	Name	Description
DRUG	Bevacizumab	15 mg/kg, IV every 21 days x 6 cycles.
DRUG	Paclitaxel	Regimen A / Treatment 1: 200 mg/m² IV over 3 hours every 21 days. Regimen B / Treatment 2: 90 mg/m² weekly x 3 of a 28-day cycle

Timeline

• Start date: 2010-02-01
• Primary completion: 2016-03-01
• Completion: 2016-06-24
• First posted: 2010-01-25
• Last updated: 2018-03-26
• Results posted: 2018-03-26

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study