A single-arm confirmatory trial of pazopanib in patients with paclitaxel-pretreated primary cutaneous angiosarcoma(JCOG1605, JCOG-PACS)
- Conditions
- Primary cutaneous angiosarcoma which has become refractory or there was intolerance to paclitaxel
- Registration Number
- JPRN-UMIN000031438
- Lead Sponsor
- Japan Clinical Oncology Group (JCOG)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- All
- Target Recruitment
- 30
Not provided
1) Synchronous or metachronous (within 3 years) malignancies except for carcinoma in situ or intramucosal tumors curatively treated with local therapy 2) Active infection requiring systemic therapy 3) Body temperature >= 38 degrees Celsius 4) Pregnant, possible pregnant, or lactating women. Within 28 days after childbirth. Men with favoring gestation of their partners. 5) Severe psychiatric disease 6) Patients who are receiving systemic administration of steroid or other immunosuppressants. 7) Patients with hypertension (>140 mmHg systolic and > 90 mmHg diastolic) that cannot be adequately controlled with antihypertensives. 8) Patients with heart disease as listed below within 6 months prior to enrollment: a) Percutaneous transluminal coronary angioplasty b) Myocardial infarction c) Unstable angina pectoris d) Coronary artery bypass grafting e) Symptomatic peripheral arterial disease f) Patients with cardiac insufficiency of NYHA class3 or 4 9) Patients with massive pleural effusion or paricardial effusion 10) Patients with interstitial lung disease 11) Patients with paralysis of intestine or ileus 12) Parients with active bleeding 13) Parients with cerebrovascular events within 6 months prior to enrollment 14) Parients with pulmonary enbolism within 6 months prior to enrollment 15) Parients with untreated deep vein thrombosis within 6 months prior to enrollment
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Progression free survival(response evaluation: every 4 weeks)
- Secondary Outcome Measures
Name Time Method Overall survival, Response rate, Disease control rate, Adverse events, Sever adverse events