ascites
Conditions
Interventions
5 patients will be given bevacizumab (therapeutic dose in combination with
radioactive tracer dose) intravenously and 5 patients will be given bevacizumab
intraperitoneally.
Sponsors
Universitair Medisch Centrum Groningen
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Malignant ascites 2. At least 18 years of age 3. WHO performance status 0-2 4. Adequate haematological, hepatic, and renal function 5. Signed written informed consent 6. Able to comply with the protocol
Exclusion criteria
Exclusion criteria: 1. Patients receiving chemotherapy 2. Radiotherapy within 14 days before the start of the study of the involved area 3. Major surgery within 28 days before the initiation of the study 4. Clinically significant cardiovascular disease 5. Pregnant or lactating women. Documentation of a negative pregnancy test must be available for pre-menopausal women with intact reproductive organs and for women less than two years after menopause 6. CNS metastases (CT-scan not mandatory) 7. Treatment with any investigational drug within 30 days before the start of the study 8. Prior allergic reaction to immunoglobulins or immunoglobulin allergy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The pharmacokinetic of intravenously and intraperitoneally administered 111In-bevacizumab will be assesed in serum and ascites. | — |
Secondary
| Measure | Time frame |
|---|---|
| -VEGF levels in ascites and serum will be assesed. -The efficacy of bevacizumab in malignant ascites will be assesed. | — |
Countries
Netherlands
Outcome results
None listed