Paclitaxel + Bevacizumab (Avastin®) for the Treatment of Metastatic or Unresectable Angiosarcoma
This trial is active, not recruiting.
|Conditions||angiosarcomas, soft tissue sarcoma|
|Treatment||paclitaxel in combination with bevacizumab|
|Start date||February 2010|
|End date||June 2014|
|Trial size||16 participants|
|Trial identifier||NCT01055028, 17755, SARCOMA0006, SU-01202010-4743|
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.
|United States||No locations recruiting|
|Other Countries||No locations recruiting|
|Endpoint classification||safety/efficacy study|
|Intervention model||single group assignment|
Drug: Paclitaxel in combination with Bevacizumab 15 mg/kg, IV Arms: Other Names: Avastin
Progression free survival
time frame: 4 months
Overall response rate
time frame: After the 3rd and 6th cycles.
Safety and overall survival
time frame: At 6 months and 12 months
Male or female participants at least 13 years old.
Inclusion Criteria: - 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 CT scan or other appropriate imaging. - Patient must have at least one objective measurable disease parameter by RECIST criteria. - Patients must have unresectable locally advanced or metastatic angiosarcoma. - Patients must have had <= 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) - Patients must not have had 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. - Patients with a history of deep venous thrombosis or pulmonary embolism must be receiving a stable dose of anticoagulation therapy for at least 2 weeks prior to registration. - Patients must not have been using any anti-platelet drugs, such as ticlopidine, clopidogrel, and cilostazol, during study or within 7 days prior to registration. The use of aspirin or other nonsteroidal anti-inflammatory drugs (NSAID) is allowed. - Patients must have an ECOG performance status 0-2. - 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 ULN and SGOT (AST) < 2 x ULN. If documented hepatic involvement, total bilirubin can be <= 3 x ULN, and AST <= 5 x ULN. - Absolute neutrophil count >= 1500/mm3 and platelet count > 100,000/mm3. - PT, INR, and PTT <= 1.5 x normal. - Patients must not have an active infection requiring parental antibiotics. - Patients must not have known HIV infection due to increase risk of infection. - Patients must have a left ventricular ejection fraction >= 50% to be eligible. - Patients must be age >= 13 years. - Women must not be pregnant or breast feeding due to potential harmful effects to the fetus/baby. Women of childbearing potential must have an HCG within 2 weeks prior to registration. - Women of childbearing potential and sexually active males must be strongly advised to use an accepted and effective method of contraception. Exclusion Criteria: - Inability to comply with study and/or follow-up procedures - Life expectancy of less than 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) - Prior history of hypertensive crisis or hypertensive encephalopathy - New York Heart Association (NYHA) Grade II or greater congestive heart failure (see Appendix D) - 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 CNS disease, except for treated brain metastasis o 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 (e.g., 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 UPC ratio >= 1.0 at screening - Known hypersensitivity to any component of bevacizumab
|Official title||Paclitaxel in Combination With Bevacizumab (Avastin®) for the Treatment of Metastatic or Unresectable Angiosarcoma|
|Principal investigator||Kristen N. Ganjoo|
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