An Open Label Multicenter Phase II Study of Bevacizumab for the Treatment of Angiosarcoma
18 Years
N/A
Both
Sarcoma
Trial Information
An Open Label Multicenter Phase II Study of Bevacizumab for the Treatment of Angiosarcoma
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Evaluate median progression-free survival of patients treated with the study drug, bevacizumab.
Outcome Description:
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).
Outcome 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
Safety Issue:
No
Principal Investigator
Mark Agulnik, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Northwestern University
Authority:
United States: Food and Drug Administration
Study ID:
NU 04S1
NCT ID:
NCT00288015
Start Date:
October 2005
Completion Date:
December 2014
Related Keywords:
- Sarcoma
- 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
- Hemangiosarcoma
- Sarcoma
Name | Location |
|---|---|
| Mayo Clinic Cancer Center | Rochester, Minnesota 55905 |
| Rebecca and John Moores UCSD Cancer Center | La Jolla, California 92093-0658 |
| M. D. Anderson Cancer Center at University of Texas | Houston, Texas 77030-4009 |
| Robert H. Lurie Comprehensive Cancer Center at Northwestern University | Chicago, Illinois 60611 |
| Fox Chase Cancer Center CCOP Research Base | Philadelphia, Pennsylvania 19140 |
