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An Open Label Multicenter Phase II Study of Bevacizumab for the Treatment of Angiosarcoma

Phase 2
18 Years
Open (Enrolling)

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Trial Information

An Open Label Multicenter Phase II Study of Bevacizumab for the Treatment of Angiosarcoma



- Determine the median progression-free survival, in terms of stable disease, of patients
with newly diagnosed or recurrent/refractory angiosarcoma treated with bevacizumab.


- 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.

Inclusion Criteria


- 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


- 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

- 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


- 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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Evaluate median progression-free survival of patients treated with the study drug, bevacizumab.

Outcome Description:

During treatment, tumor assessment 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, tumor assessment will be assessed by MRI every 3 to 4 months (for 2 years after the last bevacizumab dosage).

Outcome Time Frame:

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

Safety Issue:


Principal Investigator

Mark Agulnik, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Northwestern University


United States: Food and Drug Administration

Study ID:

NU 04S1



Start Date:

October 2005

Completion Date:

December 2014

Related Keywords:

  • Sarcoma
  • 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
  • Hemangiosarcoma
  • Sarcoma



Mayo Clinic Cancer Center Rochester, Minnesota  55905
Rebecca and John Moores UCSD Cancer Center La Jolla, California  92093-0658
M. D. Anderson Cancer Center at University of Texas Houston, Texas  77030-4009
Robert H. Lurie Comprehensive Cancer Center at Northwestern University Chicago, Illinois  60611
Fox Chase Cancer Center CCOP Research Base Philadelphia, Pennsylvania  19140