Bevacizumab in Treating Patients With Angiosarcoma

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Genentech
Information provided by (Responsible Party):
Northwestern University
ClinicalTrials.gov Identifier:
NCT00288015
First received: February 6, 2006
Last updated: April 4, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention Phase
Sarcoma
Biological: Bevacizumab
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open Label Multicenter Phase II Study of Bevacizumab for the Treatment of Angiosarcoma

Resource links provided by NLM:


Further study details as provided by Northwestern University:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    During treatment, tumor assessment will be done by MRI scan after the second cycle of study treatment, after the forth cycle of study treatment, and then every 3 cycles of treatment. After Study drug completion, tumor assessment will be assessed by MRI every 3 to 4 months (for 2 years after the last bevacizumab dosage).


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    During treatment, effect of bevacizumab on the objective response rate will be assessed by MRI scan after the second cycle of study treatment, after the forth cycle of study treatment, and then every 3 cycles of treatment in patients with angiosarcoma and epithelioid hemangioendothelioma. After Study drug completion, effect of bevacizumab on the objective response rate will be assessed by MRI scan every 3 to 4 months (for 2 years after the last bevacizumab dosage) in patients with angiosarcoma and epithelioid hemangioendothelioma.

  • 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 ] [ Designated as safety issue: No ]
    During treatment, evaluation of response will be done by MRI scan after the second cycle of study treatment, after the forth cycle of study treatment, and then every 3 cycles of treatment. After Study drug completion, evaluation of response will be assessed by MRI every 3 to 4 months (for 2 years after the last bevacizumab dosage).

  • 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 ] [ Designated as safety issue: No ]
    After Study drug completion, assessment of treatment effect of bevacizumab on duration of overall survival will be assessed by MRI every 3 to 4 months (for 2 years after the last bevacizumab dosage).

  • Evaluate the toxicity of bevacizumab in patients with angiosarcoma and epithelioid hemangioendothelioma [ Time Frame: Day 1 of every cycle ] [ Designated as safety issue: Yes ]
    Toxicity data will be collected on day 1 of every cycle during treatment


Estimated Enrollment: 30
Study Start Date: October 2005
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Bevacizumab
Bevacizumab treatment until disease progression or intolerance
Biological: Bevacizumab
Bevacizumab 15 mg/kg IV infusion given on day 1 every 21 days = (1 cycle).
Other Names:
  • rhuMAb
  • VEGF
  • Avastin

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00288015

Locations
United States, California
Rebecca and John Moores UCSD Cancer Center
La Jolla, California, United States, 92093-0658
United States, Illinois
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Chicago, Illinois, United States, 60611-3013
United States, Minnesota
Mayo Clinic Cancer Center
Rochester, Minnesota, United States, 55905
United States, Pennsylvania
Fox Chase Cancer Center CCOP Research Base
Philadelphia, Pennsylvania, United States, 19140
United States, Texas
M. D. Anderson Cancer Center at University of Texas
Houston, Texas, United States, 77030-4009
Sponsors and Collaborators
Northwestern University
Genentech
Investigators
Principal Investigator: Mark Agulnik, MD Northwestern University
  More Information

No publications provided

Responsible Party: Northwestern University
ClinicalTrials.gov Identifier: NCT00288015     History of Changes
Other Study ID Numbers: NU 04S1, NU 04S1, STU00006784
Study First Received: February 6, 2006
Last Updated: April 4, 2014
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Northwestern University:
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

Additional relevant MeSH terms:
Hemangiosarcoma
Sarcoma
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Vascular Tissue
Bevacizumab
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Growth Inhibitors
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 18, 2014