Summary

for people ages 18 years and up (full criteria)
at La Jolla, California and other locations
study started
estimated completion:

Description

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.

Official Title

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

Details

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.

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 Bevacizumab

Eligibility

For people ages 18 years and up

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/mm3

  • Platelet count ≥ 100,000/mm3

  • 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

  • Rebecca and John Moores UCSD Cancer Center
    La Jolla California 92093-0658 United States
  • M. D. Anderson Cancer Center at University of Texas
    Houston Texas 77030-4009 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Northwestern University
ID
NCT00288015
Phase
Phase 2
Study Type
Interventional
Last Updated
August 9, 2017