Bevacizumab in Treating Patients With Angiosarcoma

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.

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