Bevacizumab in Treating Patients With Angiosarcoma - Full Text View

Sponsor:	Northwestern University
Collaborator:	Genentech
Information provided by:	Northwestern University
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 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:

MedlinePlus related topics: Cancer Soft Tissue Sarcoma

Drug Information available for: Bevacizumab

U.S. FDA Resources

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 2012
Estimated Primary Completion Date:	December 2010 (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

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

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Mark Agulnik, Robert H. Lurie Comprehensive Cancer Center at 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:	May 18, 2010
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 May 21, 2012