Paclitaxel + Bevacizumab (Avastin) for the Treatment of Metastatic or Unresectable Angiosarcoma

Not Recruiting

Trial ID: NCT01055028


This is an open-label, single-arm, multi-center, Phase 2 study with Paclitaxel in combination with Bevacizumab in patients with Unresectable or Metastatic Angiosarcoma. The study aims to determine the safety and effectiveness of combining two drugs Paclitaxel and Bevacizumab in the treatment of Angiosarcoma that cannot be removed by surgery, or has spread to other parts of your body. The primary objective is to evaluate 4month non progression rate. The secondary objective is to evaluate overall response rate after 3rd and 6th cycle, median duration of response, 6th and 12th month survival, toxicity of Paclitaxel and Bevacizumab combination, toxicity of maintenance Bevacizumab and to collect paraffin-embedded tumor blocks for angiogenesis markers and tissue microarray.

Official Title

Paclitaxel in Combination With Bevacizumab (Avastin) for the Treatment of Metastatic or Unresectable Angiosarcoma

Stanford Investigator(s)

Kristen N Ganjoo
Kristen N Ganjoo

Professor of Medicine (Oncology)



   - Baseline measurements and evaluations must be obtained within 4 weeks of registration
   to the study. Abnormal PET scans will not constitute evaluable disease, unless
   verified by computed tomography (CT) scan or other appropriate imaging

   - At least 1 objective measurable disease parameter by Response Evaluation Criteria In
   Solid Tumors (RECIST) criteria

   - Unresectable locally advanced or metastatic angiosarcoma

   - ≤ 2 prior chemotherapeutic regimens for angiosarcoma

   - No prior paclitaxel, docetaxel, or bevacizumab for angiosarcoma (previous paclitaxel
   or docetaxel allowed if not given for angiosarcoma and more than 12 months has elapsed
   since last dose)

   - No evidence of other active malignancies other than carcinomas in-situ of the cervix
   or basal cell carcinoma of the skin within 6 months prior to registration

   - If history of deep venous thrombosis or pulmonary embolism, receiving a stable dose of
   anticoagulation therapy for at least 2 weeks prior to registration

   - Within 7 days prior to registration, use of any anti-platelet drugs, such as
   ticlopidine, clopidogrel, and cilostazol. The use of aspirin or other nonsteroidal
   anti-inflammatory drugs (NSAID) is allowed

   - ECOG performance status 0 to 2

   - Patients must have adequate organ function as evidenced by the following laboratory
   studies (within 2 weeks prior to registration):

   - Serum creatinine ≤ 2.0 mg/dL

   - Total bilirubin ≤ 2.0 x upper limit of normal (ULN). If documented hepatic
   involvement, can be ≤ 3 x ULN

   - Serum glutamic oxaloacetic transaminase (SGOT) or Aspartate aminotransferase (AST) < 2
   x ULN. If documented hepatic involvement, can be ≤ 5 x ULN

   - Absolute neutrophil count ≥ 1500/mm3 and platelet count > 100,000/mm3

   - Platelets ≤ 1.5 x ULN

   - International normalized ratio (INR) ≤ 1.5 x ULN

   - Partial thromboplastin time (PTT) ≤ 1.5 x ULN

   - Left ventricular ejection fraction ≥ 50%

   - ≥ 18 years

   - Women of childbearing potential must have a negative human chorionic gonadotropin
   (hCG) pregnancy test within 2 weeks prior to registration


   - Life expectancy < 12 weeks

   - Current, recent (within 4 weeks of the first infusion of this study), or planned
   participation in an another experimental drug study

   - Inadequately-controlled hypertension (defined as systolic blood pressure > 150 mmHg
   and/or diastolic blood pressure > 100 mmHg)

   - History of hypertensive crisis or hypertensive encephalopathy

   - New York Heart Association (NYHA) Grade II or greater congestive heart failure

   - History of myocardial infarction or unstable angina within 6 months prior to Day 1

   - History of stroke or transient ischemic attack within 6 months prior to Day 1

   - Known central nervous system (CNS) disease, except for treated brain metastasis.
   Treated brain metastases are defined as having no evidence of progression or
   hemorrhage after treatment and no ongoing requirement for dexamethasone, as
   ascertained by clinical examination and brain imaging (MRI or CT) during the screening
   period. Anticonvulsants (stable dose) are allowed. Treatment for brain metastases may
   include whole brain radiotherapy (WBRT), radiosurgery (RS; Gamma Knife, LINAC, or
   equivalent) or a combination as deemed appropriate by the treating physician. Patients
   with CNS metastases treated by neurosurgical resection or brain biopsy performed
   within 3 months prior to Day 1 will be excluded.

   - Significant vascular disease (eg, aortic aneurysm, requiring surgical repair or recent
   peripheral arterial thrombosis) within 6 months prior to Day 1

   - History of hemoptysis (≥ 1/2 teaspoon of bright red blood per episode) within 1 month
   prior to Day 1

   - Evidence of bleeding diathesis or significant coagulopathy (in the absence of
   therapeutic anticoagulation)

   - Major surgical procedure, open biopsy, or significant traumatic injury within 28 days
   prior to Day 1 or anticipation of need for major surgical procedure during the course
   of the study

   - Core biopsy or other minor surgical procedure, excluding placement of a vascular
   access device, within 7 days prior to Day 1

   - History of abdominal fistula or gastrointestinal perforation within 6 months prior to
   Day 1

   - Serious, non-healing wound, active ulcer, or untreated bone fracture

   - Proteinuria as demonstrated by a urine protein: creatinine ratio (UPC) ratio ≥ 1.0 at

   - Known hypersensitivity to any component of bevacizumab

   - Active infection requiring parental antibiotics

   - Known human immunodeficiency virus (HIV) infection

   - Pregnant or breast feeding

   - Inability to comply with study and/or follow-up procedures


drug: Bevacizumab

drug: Paclitaxel

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305

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