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Bevacizumab in Treating Patients With Angiosarcoma
This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), January 2009
First Received: February 6, 2006   Last Updated: June 3, 2009   History of Changes
Sponsors and Collaborators: Robert H. Lurie Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00288015
  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 II

Study Type: Interventional
Study Design: Treatment, Open Label
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 National Cancer Institute (NCI):

Primary Outcome Measures:
  • Median progression-free survival [ Designated as safety issue: No ]

Estimated Enrollment: 31
Study Start Date: October 2005
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00288015

Locations
United States, California
Rebecca and John Moores UCSD Cancer Center Recruiting
La Jolla, California, United States, 92093-0658
Contact: Clinical Trials Office - Rebecca and John Moores UCSD Cancer     858-822-5354     cancercto@ucsd.edu    
United States, Illinois
Evanston Hospital Recruiting
Evanston, Illinois, United States, 60201-1781
Contact: Clinical Trials Office - Evanston Hospital     847-570-1381        
Robert H. Lurie Comprehensive Cancer Center at Northwestern University Recruiting
Chicago, Illinois, United States, 60611-3013
Contact: Clinical Trials Office - Robert H. Lurie Comprehensive Cancer     312-695-1301     cancer@northwestern.edu    
United States, Minnesota
Mayo Clinic Cancer Center Recruiting
Rochester, Minnesota, United States, 55905
Contact: Clinical Trials Office - All Mayo Clinic Locations     507-538-7623        
United States, Pennsylvania
Fox Chase Cancer Center CCOP Research Base Recruiting
Philadelphia, Pennsylvania, United States, 19140
Contact: Clinical Trials Office - Fox Chase Cancer Center CCOP Research     215-728-2983        
United States, Texas
M. D. Anderson Cancer Center at University of Texas Recruiting
Houston, Texas, United States, 77030-4009
Contact: Clinical Trials Office - M. D. Anderson Cancer Center at the U     713-792-3245        
Sponsors and Collaborators
Robert H. Lurie Cancer Center
Investigators
Study Chair: Mark Agulnik, MD Robert H. Lurie Cancer Center
Investigator: Bruce E. Brockstein, MD Evanston NorthShore University HealthSystem
  More Information

Additional Information:
No publications provided

Responsible Party: Robert H. Lurie Comprehensive Cancer Center at Northwestern University ( Mark Agulnik )
Study ID Numbers: CDR0000456253, NU-04S1
Study First Received: February 6, 2006
Last Updated: June 3, 2009
ClinicalTrials.gov Identifier: NCT00288015     History of Changes
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
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

Study placed in the following topic categories:
Neoplasms, Connective and Soft Tissue
Soft Tissue Sarcomas
Malignant Mesenchymal Tumor
Sarcoma
Bevacizumab
Hemangiosarcoma
Angiogenesis Inhibitors
Recurrence

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

ClinicalTrials.gov processed this record on July 02, 2009