Overview

This trial is active, not recruiting.

Condition sarcoma
Treatment bevacizumab
Phase phase 2
Target VEGF
Sponsor Northwestern University
Collaborator Genentech, Inc.
Start date October 2005
End date December 2017
Trial size 30 participants
Trial identifier NCT00288015, NU 04S1, STU00006784

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Bevacizumab treatment until disease progression or intolerance
bevacizumab rhuMAb
Bevacizumab 15 mg/kg IV infusion given on day 1 every 21 days = (1 cycle).

Primary Outcomes

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

Secondary Outcomes

Measure
Evaluate the effect of bevacizumab on the objective response rate in patients with angiosarcoma and epithelioid hemangioendothelioma
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
To evaluate the duration of response
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
Assess the treatment effect of bevacizumab on duration of overall survival
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
Evaluate the toxicity of bevacizumab in patients with angiosarcoma and epithelioid hemangioendothelioma
time frame: Day 1 of every cycle

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title An Open Label Multicenter Phase II Study of Bevacizumab for the Treatment of Angiosarcoma
Principal investigator Mark Agulnik, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by Northwestern University.