Decentrialz logo
  • HIPAA Compliant
  • ISO 27001 Certified
Find Trials
About UsContact
Become a Volunteer+1 877 705 1914

Status:

COMPLETED

Bevacizumab in Treating Patients With Angiosarcoma

Lead Sponsor:

Northwestern University

Collaborating Sponsors:

Genentech, Inc.

Conditions:

Sarcoma

Eligibility:

All Genders

18+ years

Phase:

PHASE2

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...

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. Sec...

Eligibility Criteria

Inclusion

  • 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

Exclusion

    Key Trial Info

    Start Date :

    October 1 2005

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    November 10 2016

    Estimated Enrollment :

    32 Patients enrolled

    Trial Details

    Trial ID

    NCT00288015

    Start Date

    October 1 2005

    End Date

    November 10 2016

    Last Update

    June 25 2018

    Active Locations (5)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 2 (5 locations)

    1

    Rebecca and John Moores UCSD Cancer Center

    La Jolla, California, United States, 92093-0658

    2

    Robert H. Lurie Comprehensive Cancer Center at Northwestern University

    Chicago, Illinois, United States, 60611-3013

    3

    Mayo Clinic Cancer Center

    Rochester, Minnesota, United States, 55905

    4

    Fox Chase Cancer Center CCOP Research Base

    Philadelphia, Pennsylvania, United States, 19140