Bevacizumab in Treating Patients With Angiosarcoma
- Conditions
- Sarcoma
- Interventions
- Biological: Bevacizumab
- Registration Number
- NCT00288015
- Lead Sponsor
- Northwestern University
- Brief Summary
RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor.
PURPOSE: This phase II trial is studying how well bevacizumab works in treating patients with angiosarcoma.
- Detailed Description
OBJECTIVES:
Primary
* Determine the median progression-free survival, in terms of stable disease, of patients with newly diagnosed or recurrent/refractory angiosarcoma treated with bevacizumab.
Secondary
* Evaluate the treatment effect of bevacizumab on the objective response rate as assessed by modified RECIST criteria in patients with angiosarcoma.
* Evaluate the duration of response.
* Assess the treatment effect of bevacizumab on duration of overall survival.
* Explore the objective response by target tumor density changes on CT scan.
* Evaluate the safety and tolerability of bevacizumab in patients with angiosarcoma.
OUTLINE: This is an open-label, multicenter study.
Patients receive bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 3 to 4 months for 2 years.
PROJECTED ACCRUAL: A total of 31 patients will be accrued for this study.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 32
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Bevacizumab Bevacizumab Bevacizumab treatment until disease progression or intolerance
- Primary Outcome Measures
Name Time Method Median Progression-free Survival of Patients Treated With the Study Drug as Defined by RECIST Criteria. After cycles 2 and 4, then every 3 cycles thereafter while on treatment (1 cycle = 21 days); every 3-4 months after treatment up to 2 years. During treatment, tumor assessment was done by MRI scan after the second cycle of study treatment, after the forth cycle of study treatment, and then every 3 cycles of treatment thereafter. After Study drug completion, tumor assessment by MRI was done every 3 to 4 months (for up to 2 years after the last bevacizumab dosage).
Responses were categorized according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria version 1.0.
Progressive Disease (PD) was defined as having at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions.
- Secondary Outcome Measures
Name Time Method Duration of Response. After cycles 2 and 4, then every 3 cycles thereafter while on treatment (1 cycle = 21 days); every 3-4 months after treatment up to 2 years. During treatment, evaluation of response will be done by MRI scan after the second cycle of study treatment, after the forth cycle of study treatment, and then every 3 cycles of treatment. After Study drug completion, evaluation of response will be assessed by MRI every 3 to 4 months (for 2 years after the last bevacizumab dosage).
Assess the Treatment Effect of Bevacizumab on Duration of Overall Survival After cycles 2 and 4, then every 3 cycles thereafter while on treatment (1 cycle = 21 days); every 3-4 months after treatment up to 2 years After Study drug completion, assessment of treatment effect of bevacizumab on duration of overall survival will be assessed by MRI every 3 to 4 months (for 2 years after the last bevacizumab dosage).
Objective Response Rate in Patients Treated With Bevacizumab. After cycles 2 and 4, then every 3 cycles thereafter while on treatment (1 cycle = 21 days); every 3-4 months after treatment up to 2 years. Objective response rate will be measured per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI:
Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions.
Stable Disease, neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study.
Progressive Disease, defined as having at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions.Evaluate the Toxicity of Bevacizumab. Day 1 of every cycle, on average every 21 days until end of treatment up to 2 years. Toxicity data for bevacizumab will be collected on day 1 of every cycle (1 cycle = 21 days) during treatment according to the National Cancer Institute's Common Toxicity Criteria for adverse events version 3.0 (CTCAE v3.0). In general adverse events (AEs) will be graded according to the following:
Grade 1 Mild AE Grade 2 Moderate AE Grade 3 Severe AE Grade 4 Life-threatening or disabling AE Grade 5 Death related to AE
Trial Locations
- Locations (5)
Rebecca and John Moores UCSD Cancer Center
🇺🇸La Jolla, California, United States
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
🇺🇸Chicago, Illinois, United States
Fox Chase Cancer Center CCOP Research Base
🇺🇸Philadelphia, Pennsylvania, United States
Mayo Clinic Cancer Center
🇺🇸Rochester, Minnesota, United States
M. D. Anderson Cancer Center at University of Texas
🇺🇸Houston, Texas, United States