A phase II trial assessing bevacizumab in the treatment of advanced or metastatic angiosarcoma

• Conditions: patients with advanced or metastatic angiosarcoma

• Registration Number: EUCTR2004-004546-41-FI
• Lead Sponsor: Helsinki University Central Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-01-03
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 10

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 <2+.
7.Women of childbearing potential must have a negative serum pregnancy test done 1 week prior to the administration of the study drug. She and her partner should prevent pregnancy (oral contraceptives, intrauterine contraceptive device, barrier method of contraception in conjunction with spermicidal jelly or surgically sterile) up to at least 6 months after last treatment completion or the last drug dose, whatever happens first
8.Signed written informed consent according to ICH/GCP and the local regulations (approved by the Independent Ethics Committee [IEC]) will be obtained prior to any study specific screening procedures
9.Patient must be able to comply with the protocol

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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).