Phase 2
N=32
Bevacizumab in Treating Patients With Angiosarcoma
Sarcoma
Bottom Line
View on ClinicalTrials.gov: NCT00288015 ↗Enrolled (actual)
32
Serious AEs
26.7%
Results posted
Jun 2018
Primary outcome: Primary: Median Progression-free Survival of Patients Treated With the Study Drug as Defined by RECIST Criteria. — 12.4 Weeks
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Bevacizumab (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Northwestern University
- Primary completion
- Jun 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Median Progression-free Survival of Patients Treated With the Study Drug as Defined by RECIST Criteria. |
12.4 | — |
| SECONDARY Objective Response Rate in Patients Treated With Bevacizumab. |
4; 15; 11 | — |
| SECONDARY Duration of Response. |
— | — |
| SECONDARY Assess the Treatment Effect of Bevacizumab on Duration of Overall Survival |
107 | — |
| SECONDARY Evaluate the Toxicity of Bevacizumab. |
26; 4; 5; 7; 3; 5 | — |
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.
Eligibility Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed angiosarcoma
- Any stage disease
- Must be deemed not surgically resectable (complete resection) and/or no other therapeutic modality is known to be curative
- No angiosarcoma of a vessel wall
- Newly diagnosed or recurrent/refractory disease
- No prior tumor-related hemorrhage (any grade)
- Measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as ≥ 20 mm with conventional techniques or as ≥ 10 mm with spiral CT scan
- No CNS disease, brain metastases, or primary brain tumors
PATIENT CHARACTERISTICS:
- ECOG performance status of 0 or 1
- Absolute granulocyte count ≥ 1,500/mm^3
- Platelet count ≥ 100,000/mm^3
- Hemoglobin ≥ 9 gm/dL (transfusion and epoetin alfa allowed)
- Creatinine ≤ 1.5 times upper limit of normal (ULN)
- Urine protein:creatinine ratio ≤ 1.0
- Total bilirubin ≤ 1.5 mg/dL
- Aspartate aminotransferase 49% for patients with prior anthracycline therapy, ischemic cardiac disease, or history of heart failure
- No uncontrolled active infection
- No uncontrolled high blood pressure (defined as > 150/100 mm Hg)
- No symptomatic congestive heart failure (New York Heart Association class II-IV), unstable angina, cardiac arrhythmia, or myocardial infarction within the past 6 months
- No psychiatric illness or social situation that would limit study compliance
- No serious, nonhealing wound, ulcer, or bone fracture
- No evidence of bleeding diathesis or coagulopathy
- No clinically significant peripheral vascular disease
- Not pregnant or nursing
- No seizures not controlled with standard medical therapy
- No embolic or hemorrhagic stroke or prior transient ischemic attack
- No history of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 6 months
- No significant traumatic injury within the past 6 weeks
PRIOR CONCURRENT THERAPY:
- No prior therapy with bevacizumab or other antiangiogenesis treatment
- No major surgical procedure or open biopsy within the past 6 weeks
- No more than 2 prior chemotherapy regimens
- No fine-needle aspiration or core-needle biopsy or other minor surgical procedure within the past 7 days
- No radiotherapy within the past 28 days
- No concurrent chronic daily treatment with aspirin > 325 mg/day or nonsteroidal anti-inflammatory medications
- No concurrent warfarin or any other anticoagulant (any dose)
- No concurrent radiotherapy
- No concurrent major surgery
Data sourced from ClinicalTrials.gov (NCT00288015). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.