patients with advanced or metastatic angiosarcoma
Conditions
Sponsors
Helsinki University Central Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Histologically confirmed diagnosis of angiosarcoma 2. Age over 18 3. Measurable disease either by radiology or by caliper 4. Surgically inoperable AS 5. ECOG performance status =2 6. Urine dipstick of proteinuria =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to Day 0 (Patients must have recovered from any major surgery), or anticipation of need for major surgical procedure during the course of the study 2. Ongoing anti-neoplastic therapy with drug treatments or radiotherapy (minimum 4 weeks interval before study inclusion) 3. Planned radiotherapy for underlying disease 4. Clinical or radiological evidence of CNS metastases 5. Serious non-healing wound or ulcer 6. Bleeding diathesis or coagulopathy 7. Uncontrolled hypertension 8. Clinically significant active cardiovascular disease for example cerebrovascular accidents (= 6 months), myocardial infarction (= 6 months), unstable angina, New York Heart Association (NYHA) grade II or greater congestive heart failure, serious cardiac arrhythmia requiring medication 9. Evidence of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates use of an investigational drug or patient at high risk from treatment complications 10. Ongoing treatment with aspirin (> 325 mg/day) or other medications known to predispose to gastrointestinal ulceration 11. Pregnancy (positive serum pregnancy test) and lactation 12. Any other serious or uncontrolled illness which, in the opinion of the investigator, makes it undesirable for the patient to enter the trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Response rate according to RECIST criteria or clinical benefit defined as complete response, partial response or stable disease for at least 24 weeks;Secondary Objective: time to tumor progression, overall survival and toxicity;Primary end point(s): The response rate of the trial treatment is evaluated according the RECIST quidelines by compuer tomography or magnetic resonance imaging or in the case of superfisial tumor by ruler. The evaluation is done just before the trial initiation and thereafter every 8 weeks (in the case of superfisial tumor every 4 weeks). | — |
Countries
Finland
Outcome results
None listed