Primary cutaneous angiosarcoma which has become refractory or there was intolerance to paclitaxel
Conditions
Interventions
A: Pazopanib group(Pazopanib 800mg is taken orally once daily until disease recurrence or progression)
Sponsors
Japan Clinical Oncology Group (JCOG)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Histologically confirmed primary cutaneous angiosarcoma not associated with lymphedema or radiation. 2) Primary or metastatic lesions. (histological evaluation is not essential for metastatic lesions) 3) Absence of intracranial metastasis 4) Age >= 20 and =< 85 5) ECOG performance status of 0 or 1. 6) Past history of paclitaxel monotherapy as a first line treatment with or without combination of any local treatment (surgery and/or radiation therapy) 7) No past history of any systemic chemotherapy other than paclitaxel 8) Refractory disease or unable to tolerate paclitaxel 9) A Measurable lesion is not required 10) No prior use of antiangiogenic agents 11) Absense of non-healing wound 12) Adequate organ and marrow function as defined below within 14 days prior to enrollment: a) Absolute neutrophil count >= 1,500 /mm3 b) Hemoglobin >= 9.0 g/dL c) Platelets >= 10X104 /mm3 d) Total bilirubin =< 2.25 mg/dL e) AST=< 75 U/L f) Male:ALT=< 105 U/L, female: ALT=< 57.5 U/L g) Renal function: serum creatinine =< 1.5 mg/dL, or, if >1.5 mg/dL, calculated creatinine clearance > 50 mL/min h) PT-INR <= 1.38 i) APTT <= 44.4 sec j) TSH: 0.5-4.5 microU/mL k) FT3: 2.0-4.0 pg/mL l) FT4: 0.9-1.8 ng/dL m) Left ventricular ejection fraction >= 50% n) Corrected QT interval <= 480 ms o) Negative urinary protein, or, if not negative, 24-hour urinary protein excretion <=0.15g 13) Written informed consent
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression free survival(response evaluation: every 4 weeks) | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival, Response rate, Disease control rate, Adverse events, Sever adverse events | — |
Countries
Japan
Contacts
Public ContactKohei Oashi
JCOG1605 Coordinating Office Division of Dermatology, Saitama Cancer Center
Outcome results
None listed