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

Phase 2

Terminated

• Conditions: Angiosarcomas; Soft Tissue Sarcoma
• Interventions: Drug: Bevacizumab; Drug: Paclitaxel

• Registration Number: NCT01055028
• Lead Sponsor: Stanford University

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 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2010-01-21
• Study First Submitted QC: 2010-01-22
• Study First Posted: 2010-01-25
• Study Start: 2010-02
• Primary Completion: 2016-03
• Study Completion: 2016-06-24
• Results First Submitted: 2016-12-19
• Status Verified: 2017-05
• Results First Submitted QC: 2018-02-23
• Last Update Submitted: 2018-02-23
• Results First Posted: 2018-03-26
• Last Update Posted: 2018-03-26

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Regimen B / Treatment 2	Bevacizumab	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.
Regimen A / Treatment 1	Bevacizumab	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.
Regimen B / Treatment 2	Paclitaxel	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.
Regimen A / Treatment 1	Paclitaxel	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.

Primary Outcome Measures

Name	Time	Method
Progression-free Survival (PFS)	4 months	The primary objective of this study was to evaluate progression-free survival (PFS or non-progression rate) through 4 months from start of treatment.; Progression is defined as ≥ 20% increase in the sum of the longest diameter of target lesions, as compared to the baseline measurements, and/or the appearance of one or more new lesion(s).

Secondary Outcome Measures

Name	Time	Method
Overall Survival (OS) at 6 Months	6 months	Assessed as the number of subjects known to remain alive 6 months after study entry
Overall Survival (OS) at 12 Months	12 months	Assessed as the number of subjects known to remain alive 12 months after study entry
Overall Response Rate After 3 Cycles	12 weeks	Response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) Criteria, per protocol. Overall response rate (ORR) is the sum of the Complete Response (CR) + Partial Response (PR) rates. The ORR for participants after 3 cycles of treatment (12 weeks) is expressed as the number and proportion of subjects.; RECIST Criteria; * CR = Disappearance of all target lesions; * PR = ≥ 30% decrease in the sum of the longest diameter of target lesions; * Progressive disease (PD) = 20% increase in the sum of the longest diameter of target lesions, and/or the appearance of one or more new lesion(s),; * Stable disease (SD) = Small changes that do not meet any of the above criteria
Overall Response Rate After 6th Cycle	6 Cycles	Response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) Criteria, per protocol. Overall response rate (ORR) is the sum of the Complete Response (CR) + Partial Response (PR) rates. The ORR for participants after 6 cycles of treatment (24 weeks) is expressed as the number and proportion of subjects.; RECIST Criteria; * CR = Disappearance of all target lesions; * PR = ≥ 30% decrease in the sum of the longest diameter of target lesions; * Progressive disease (PD) = 20% increase in the sum of the longest diameter of target lesions, and/or the appearance of one or more new lesion(s),; * Stable disease (SD) = Small changes that do not meet any of the above criteria

Trial Locations

Locations (3)

Santa Monica Sarcoma Center; 🇺🇸 Santa Monica, California, United States

MD Anderson Sarcoma Center; 🇺🇸 Houston, Texas, United States

Stanford University Medical Center; 🇺🇸 Stanford, California, United States