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SarcomaPhase 2NCT00288015

Bevacizumab in Treating Patients With Angiosarcoma

A Phase 2 study testing Bevacizumab in people with Sarcoma, run by Northwestern University at 5 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Sarcoma
What is being tested?
Bevacizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
32 participants
Where
5 sitesUnited States
Study dates
Oct 2005to 10 Nov 2016
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

United States5 sites

  • Robert H. Lurie Comprehensive Cancer Center at Northwestern University

    Chicago, Illinois, 60611-3013

  • M. D. Anderson Cancer Center at University of Texas

    Houston, Texas, 77030-4009

  • Rebecca and John Moores UCSD Cancer Center

    La Jolla, California, 92093-0658

  • Fox Chase Cancer Center CCOP Research Base

    Philadelphia, Pennsylvania, 19140

  • Mayo Clinic Cancer Center

    Rochester, Minnesota, 55905

Other trials in United States

About this study

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

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.

Read the 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.

Conditions
Sarcoma
Being tested
Bevacizumab
Keywords
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
Medical subject headings
Sarcoma, Hemangiosarcoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BevacizumabBiological

    Also called rhuMAb, VEGF, Avastin

    Bevacizumab 15 mg/kg IV infusion given on day 1 every 21 days = (1 cycle).

Study groups in NCT00288015
Study groupRoleWhat they receive
BevacizumabExperimentalBevacizumab treatment until disease progression or intolerance
Receives: Biological: Bevacizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Median Progression-free Survival of Patients Treated With the Study Drug as Defined by RECIST Criteria.

    During treatment, tumor assessment was 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 thereafter. After Study drug completion, tumor assessment by MRI was done every 3 to 4 months (for up to 2 years after the last bevacizumab dosage).

    Responses were categorized according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria version 1.0.

    Progressive Disease (PD) was defined as having at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions.

    Measured: 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.

Secondary outcomes (4)

  1. Objective Response Rate in Patients Treated With Bevacizumab.

    Objective response rate will be measured per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI:

    Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions.

    Stable Disease, neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study.

    Progressive Disease, defined as having at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions.

    Measured: 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.

  2. Duration of Response.

    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).

    Measured: 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.

  3. Assess the Treatment Effect of Bevacizumab on Duration of Overall Survival

    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).

    Measured: 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

  4. Evaluate the Toxicity of Bevacizumab.

    Toxicity data for bevacizumab will be collected on day 1 of every cycle (1 cycle = 21 days) during treatment according to the National Cancer Institute's Common Toxicity Criteria for adverse events version 3.0 (CTCAE v3.0). In general adverse events (AEs) will be graded according to the following:

    Grade 1 Mild AE Grade 2 Moderate AE Grade 3 Severe AE Grade 4 Life-threatening or disabling AE Grade 5 Death related to AE

    Measured: Day 1 of every cycle, on average every 21 days until end of treatment up to 2 years.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Feb 2006 (estimated)
  2. Study startOct 2005
  3. Primary completion6 Jun 2013
  4. Study completion10 Nov 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
32 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00288015
Sponsor's protocol ID
NU 04S1
Other IDs
NU 04S1, STU00006784
Status last verified
Jun 2018
First submitted
6 Feb 2006
Last updated
25 Jun 2018
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Bevacizumab in people with Sarcoma, run by Northwestern University at 5 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 Jun 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Median Progression-free Survival of Patients Treated With the Study Drug as Defined by RECIST Criteria. (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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00288015.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2018.

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Bevacizumab in Treating Patients With Angiosarcoma | AzTrials