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

Part of paid clinical trials in Santa Monica, California.

Sponsor
Stanford University
Study ID
NCT01055028
Phase
PHASE2
Status
Terminated

Conditions

  • Angiosarcomas
  • Soft Tissue Sarcoma

Eligibility Criteria

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

Interventions

  • Bevacizumab — DRUG
    15 mg/kg, IV every 21 days x 6 cycles.
  • Paclitaxel — DRUG
    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

Study Details

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.

Key Dates

First listed
Jan 25, 2010
Start date
Feb 28, 2010
Status verified
May 2017
Primary completion
Mar 31, 2016
Completion
Jun 24, 2016

Study Design

Enrollment
18 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Regimen A / Treatment 1
    Participants were to receive paclitaxel 200 mg/m² intravenously over 3 hours every 21 days followed by bevacizumab 15 mg/kg intravenously over (cycle 1: 90 min; cycle 2: 60 min; cycles 3 to 6: 30 min) every 21 days x 6 cycles. Maintenance bevacizumab (MB), 15 mg/kg once every 21 days intravenously for a maximum of 8 cycles, was initiated after the completion of paclitaxel + bevacizumab combination.
  • Experimental: Regimen B / Treatment 2
    Patients were to receive paclitaxel 90 mg/m² weekly x 3 of a 28-day cycle followed by bevacizumab 15 mg/kg intravenously over (cycle 1: 90 min; cycle 2: 60 min; cycles 3 to 6: 30 min) every 21 days x 6 cycles. Maintenance bevacizumab (MB), 15 mg/kg once every 21 days intravenously for a maximum of 8 cycles, was initiated after the completion of paclitaxel + bevacizumab combination.

Primary Outcome Measure

Progression-free Survival (PFS) [ Time Frame: 4 months ]

Locations (3)

FacilityCityStateZIPSite coordinators
Santa Monica Sarcoma CenterSanta MonicaCalifornia90403-
Stanford University Medical CenterStanfordCalifornia94305-
MD Anderson Sarcoma CenterHoustonTexas77030-

Find similar trials in Santa Monica, CA

By research site
Santa Monica Sarcoma Center· Santa Monica, CAStanford University Medical Center· Stanford, CAMD Anderson Sarcoma Center· Houston, TX

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