Bevacizumab in Treating Patients With Angiosarcoma

NCT ID: NCT00288015

Last Updated: 2018-06-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-10-31
• Study Completion Date: 2016-11-10

Brief 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.

Detailed 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.

Conditions

Sarcoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Bevacizumab

Bevacizumab treatment until disease progression or intolerance

Group Type: EXPERIMENTAL

Bevacizumab

Intervention Type: BIOLOGICAL

Bevacizumab 15 mg/kg IV infusion given on day 1 every 21 days = (1 cycle).

Interventions

Bevacizumab

Bevacizumab 15 mg/kg IV infusion given on day 1 every 21 days = (1 cycle).

Intervention Type: BIOLOGICAL

Other Intervention Names

rhuMAb; VEGF; Avastin

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Genentech, Inc.

INDUSTRY

Sponsor Role: collaborator

Northwestern University

OTHER

Sponsor Role: lead

Responsible Party

Mark Agulnik

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mark Agulnik, MD

Role: PRINCIPAL_INVESTIGATOR

Northwestern University

Locations

Rebecca and John Moores UCSD Cancer Center

La Jolla, California, United States

Robert H. Lurie Comprehensive Cancer Center at Northwestern University

Chicago, Illinois, United States

Mayo Clinic Cancer Center

Rochester, Minnesota, United States

Fox Chase Cancer Center CCOP Research Base

Philadelphia, Pennsylvania, United States

M. D. Anderson Cancer Center at University of Texas

Houston, Texas, United States

Countries

United States

Other Identifiers

NU 04S1

Identifier Type: OTHER

Identifier Source: secondary_id

STU00006784

Identifier Type: OTHER

Identifier Source: secondary_id

NU 04S1

Identifier Type: -

Identifier Source: org_study_id