Bevacizumab in Treating Patients With Angiosarcoma
Condition: Sarcoma
MeSH terms: Sarcoma; Hemangiosarcoma
Intervention: Bevacizumab
Intervention description: Bevacizumab 15 mg/kg IV infusion given on day 1 every 21 days = (1 cycle).
Intervention MeSH terms: Bevacizumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 32.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: adult angiosarcoma; recurrent adult soft tissue sarcoma; stage I adult soft tissue sarcoma; stage II adult soft tissue sarcoma; stage III adult soft tissue sarcoma; stage IV adult soft tissue sarcoma

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 < 5 times ULN

          -  Alkaline phosphatase < 5 times ULN

          -  PT/INR ≤ 1.5 times ULN

          -  PTT ≤ 1.5 times ULN

          -  Fertile patients must use effective contraception

          -  Ejection fraction > 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