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Bevacizumab in Treating Patients With Angiosarcoma

Information source: Northwestern University
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Sarcoma

Intervention: Bevacizumab (Biological)

Phase: Phase 2

Status: Active, not recruiting

Sponsored by: Northwestern University

Official(s) and/or principal investigator(s):
Mark Agulnik, MD, Principal Investigator, Affiliation: Northwestern University

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.

Clinical Details

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

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

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

Secondary outcome:

Evaluate the effect of bevacizumab on the objective response rate in patients with angiosarcoma and epithelioid hemangioendothelioma

To evaluate the duration of response

Assess the treatment effect of bevacizumab on duration of overall survival

Evaluate the toxicity of bevacizumab in patients with angiosarcoma and epithelioid hemangioendothelioma

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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Rebecca and John Moores UCSD Cancer Center, La Jolla, California 92093-0658, United States

Robert H. Lurie Comprehensive Cancer Center at Northwestern University, Chicago, Illinois 60611-3013, United States

Mayo Clinic Cancer Center, Rochester, Minnesota 55905, United States

Fox Chase Cancer Center CCOP Research Base, Philadelphia, Pennsylvania 19140, United States

M. D. Anderson Cancer Center at University of Texas, Houston, Texas 77030-4009, United States

Additional Information

Starting date: October 2005
Last updated: April 9, 2015

Page last updated: August 20, 2015

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