Bevacizumab in Treating Patients With Angiosarcoma

Northwestern University

Status and phase

Completed

Phase 2

Conditions

Sarcoma

Treatments

Biological: Bevacizumab

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00288015

STU00006784 (Other Identifier)

NU 04S1 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

32 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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