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Study Summary
No. 2004-0802:.......Sarcoma......Robert S. Benjamin......Sarcoma Medical Oncology
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Study Summary Title
Study Summary
Number:
2004-0802
Study Title:An Open Label Multicenter Phase II Study of Bevacizumab for the Treatment of Angiosarcoma
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Physician New Patient Referral
Name:Robert S. BenjaminPatients Call:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Dept:Sarcoma Medical OncologyReferring MD
Call:
800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Phone:713-792-3626
Contact us about clinical trials
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General Information
Disease Group:SarcomaSupported By:N/A
Phase of Study:Phase IIReturn
Visit:
Treatments are given every 21 days on day 1 (1 cycle). Patients will return to
MDACC every three weeks and on an as needed basis.
Treatment
Agents:
BevacizumabHome Care:None anticipated.
Treatment Loc:Independent Multicenter Arrangements
Estimated
Length of Stay
in Houston:
No hospitalizations in this protocol.
Description/
Intervention:
The goal of this clinical research study is to find out if Avastin
(bevacizumab) can shrink or slow the growth of angiosarcoma. The safety of
this drug will also be studied.
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Study Objectives / Outcomes
Primary: 1. Estimate the median progression free survival of patients with angiosarcoma treated with bevacizumab.


Secondary: 1. Evaluate the treatment effect of bevacizumab on the objective response rate as assessed by modified RECIST criteria in patients with angiosarcoma.

2. To evaluate the duration of response.

3. To assess treatment effect of bevacizumab on duration of overall survival.

4. To explore the objective response by target tumor density changes on CT.

5. Evaluate the safety and tolerability of bevacizumab in patients with angiosarcoma.
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Study Status Information
Study Activation / Registration Date:06/28/2005
IRB Review and Approval Date:03/02/2005
Study Type:Therapeutic
Recruitment Status:Closed
Projected Accrual:30
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Enrollment Eligibility
If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

Inclusion Criteria:1) Histologically confirmed angiosarcoma. (except patients with angiosarcoma of a vessel wall are not eligible for this study).

2) Any stage allowed, although angiosarcoma must be deemed not surgically resectable (complete resection) and/or for which no other therapeutic modality that is known to be curative.

3) Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as greater than or equal to 20 mm with conventional techniques or as greater than or equal to 10mm with spiral CT scan.

4) Previous surgery, radiation and less than or equal to 3 prior chemotherapy treatment regimens are permitted. Prior treatment is not mandatory (patients may be untreated). Prior therapy with bevacizumab or other antiangiogenesis treatment is not allowed. Patients may not have received radiation therapy within 28 days of study entry (and may not receive radiation during the course of this study).

5) Patients must have ECOG performance status 0 or 1.

6) Organ function permitted (within 21 days of the start of therapy): 1. Absolute granulocyte count greater than or equal to 1,500/ul 2. Platelets greater than or equal to 100,000/ul 3. Hemoglobin greater than or equal to 9 gm/dL [patients may be transfused and treated with epoetin to meet this requirement]

7) Organ function permitted (within 21 days of the start of therapy): 1. Creatinine less than or equal to 1.5 x ULN 2. Urine protein:creatinine ratio (on spot urinalysis) of less than or equal to 1.0 3. Total bilirubin less than or equal to 1.5 mg/dL 4. Aspartate aminotransferase less than 5 x ULN. 5. Alkaline phosphatase less than 5 x ULN 6. PT/INR less than or equal to 1.5 x ULN 7. PTT less than or equal to 1.5 x ULN

8) Age greater than or equal to 18 years.

9) All patients must have given signed, informed consent prior to registration on study.

10) Women of childbearing potential and sexually active males must commit to the use of effective contraception while on study.

11) For patients who received prior anthracycline therapy or with prior ischemic cardiac disease or history of heart failure must have baseline MUGA or echo to assess ejection fraction - needs to be greater than 49% for study participation.

Exclusion Criteria:1) Patients must not be on chronic daily treatment with aspirin greater than 325 mg/day or non-steroidal inflammatory medications.

2) Patients with the following uncontrolled intercurrent medical conditions are excluded: 1. Active infection 2. Uncontrolled high blood pressure (defined as > 140/90 mmHg) 3. Symptomatic congestive heart failure (defined as NYHA >/= to II) 4. Unstable angina 5. Cardiac arrhythmia 6. Myocardial infarction < 6 months prior to registration 7. Psychiatric illness/social situation that would limit compliance with study requirements 8. Serious, non-healing wound, ulcer, or bone fracture 9. Evidence of bleeding diathesis or coagulopathy. 10. Clinically significant peripheral vascular disease.

3) Patients with the following history of evidence of central nervous system disease are excluded: 1. Brain metastases 2. Primary brain tumor 3. Seizures not controlled with standard medical therapy 4. Embolic or hemorrhagic stroke or prior transient ischemic attack.

4) Patients who have undergone the following invasive procedures are excluded: 1. Major surgical procedure, open biopsy, or significant traumatic injury with 6 weeks prior to day 1 of treatment. 2. Fine needle aspiration or core needle biopsy or other minor surgical procedure within 7 days prior to day 1 of treatment. 3. Anticipation of the need for a major surgical procedure during the course of the study.

5) Women who are pregnant or lactating are not eligible for this study.

6) History of abdominal fistula, GI perforation, or intra-abdominal abscess within 6 months of Day 0 is an exclusion criteria.

7) Patients with prior tumor-related hemorrhage (any grade) are not eligible.

8) Patients on warfarin or any other anticoagulant (any dose) are not eligible.

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Links
Registration Number: NCT00288015
Study Information on Clinical Trials Registry (clinicaltrials.gov)

Other Links:
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Results


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